ClearanceBrief
Company ยท US

Terumo Cardiovascular Systems Corporation

FDA 510(k) clearances and medical device recalls filed under this name, 2000 to 2024. Name variants (Inc, Corp, punctuation) are merged.

74510(k) clearances (0 in 12 months)
571recalls (0 in 12 months)
503recalls that name a 510(k)

Product codes

CodeDeviceRecords
DTQConsole, Heart-Lung Machine, Cardiopulmonary Bypass211
DWFCatheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass153
DRYMonitor, Blood-Gas, On-Line, Cardiopulmonary Bypass42
DTZOxygenator, Cardiopulmonary Bypass33
MJJCpb Check Valve, Retrograde Flow, In-Line32
DTRHeat-Exchanger, Cardiopulmonary Bypass20
KFMPump, Blood, Cardiopulmonary Bypass, Non-Roller Type19
DWCController, Temperature, Cardiopulmonary Bypass16
DTWMonitor And/Or Control, Level Sensing, Cardiopulmonary Bypass15
GCYApparatus, Suction, Single Patient Use, Portable, Nonpowered12
OEZCardiovascular Procedure Kit12
DTLAdaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass7
DTMFilter, Blood, Cardiopulmonary Bypass, Arterial Line7
N/A7
74D6
DTNReservoir, Blood, Cardiopulmonary Bypass6
GCJLaparoscope, General & Plastic Surgery6
DWBPump, Blood, Cardiopulmonary Bypass, Roller Type5
KRLDetector, Bubble, Cardiopulmonary Bypass5
DTSSucker, Cardiotomy Return, Cardiopulmonary Bypass3

Latest 510(k) clearances

Decided510(k)Device and applicantCode
Apr 25, 2024K234065CDI OneView Monitoring System
Terumo Cardiovascular Systems Corporation
DRY
Apr 18, 2023K221895Terumo Advanced Perfusion System 1
Terumo Cardiovascular Systems Corporation
DTQ
Nov 18, 2021K200091Capiox iCP Centrifugal Pump
Terumo Cardiovascular Systems Corporation
KFM
Nov 2, 2018K182110CDI Blood Parameter Monitoring System 550
Terumo Cardiovascular Systems Corporation
DRY
Jun 22, 2018K180950Terumo Capiox NX19 Oxygenator with Reservoir (east Orientation), Terumo Capiox NX19 Oxygenator with Reservoir (west Orie
Terumo Cardiovascular Systems Corporation
DTZ
Mar 29, 2018K172071Terumo Capiox NX19 Oxygenator with Reservoir (east orientation ), Terumo Capiox NX19 Oxygenator with Reservoir (west or
Terumo Cardiovascular Systems Corporation
DTZ
Aug 17, 2017K172220Advanced Perfusion System 1
Terumo Cardiovascular Systems Corporation
DTQ
Jun 7, 2017K163531Advanced Perfusion System 1
Terumo Cardiovascular Systems Corporation
DTQ
Nov 17, 2016K162843Small (4) Roller Pump for the Terumo Advanced Perfusion System 1, Large (6) Roller Pump for the Terumo Advanced Perfusio
Terumo Cardiovascular Systems Corporation
DWB
Apr 21, 2016K160206VirtuoSaph Plus Endoscopic Vessel Harvesting System
Terumo Cardiovascular Systems Corporation
GEI
Dec 16, 2015K153376Advanced Perfusion System 1
Terumo Cardiovascular Systems Corporation
DTQ
Dec 3, 2015K153213Capiox RX Hollow Fiber Oxygenator with/without Hardshell Reservoir
Terumo Cardiovascular Systems Corporation
DTZ
Dec 2, 2015K153143Capiox Advance Hardshell Reservoir
Terumo Cardiovascular Systems Corporation
DTN
Dec 2, 2015K153140Terumo Capiox SX18 Oxygenator/ Hardshell Reservoir, Terumo Capiox SX18 Oxygenator/ Hardshell Reservoir with Xcoating, Te
Terumo Cardiovascular Systems Corp.
DTZ
Nov 19, 2015K151791Terumo Capiox FX15 Advance Oxygenator with Integrated Arterial Filter and Reservoir, Terumo Capiox FX25 Advance Oxygenat
Terumo Cardiovascular Systems Corporation
DTZ
Oct 20, 2015K151389Terumo Capiox FX15 Advance Oxygenator with Integrated Arterial Filter and Hardshell Reservoir
Terumo Cardiovascular Systems Corporation
DTZ
Aug 27, 2015K151349Advanced Perfusion System 1
Terumo Cardiovascular Systems Corporation
DTQ
May 5, 2015K150536Terumo Circuit Tubing
Terumo Cardiovascular Systems Corporation
DWF
May 1, 2015K150542Terumo Pump Tubing
Terumo Cardiovascular Systems Corporation
DWE
Jan 29, 2015K142500One Way Soft Valve
Terumo Cardiovascular Systems Corporation
MJJ
Oct 31, 2014K140008VIRTUOSAPH PLUS ENDOSCOPIC VESSEL HARVESTING SYSTEM
Terumo Cardiovascular Systems Corporation
GEI
Jul 25, 2014K133658CDI BLOOD PARAMETER MONITORING SYSTEM 500
Terumo Cardiovascular Systems Corp.
DRY
Jun 2, 2014K140774TERUMO CAPIOX FX15 AND FX25 HOLLOW FIBER OXYGENATOR/RESERVOIR
Terumo Cardiovascular Systems Corporation
DTZ
Feb 27, 2014K132811SARNS SOFT-FLOW EXTENDED AORTIC CANNULA
Terumo Cardiovascular Systems Corporation
DWF
Feb 20, 2014K131041ADVANCED PERFUSION SYSTEM 1
Terumo Cardiovascular Systems Corp.
DTQ
Feb 18, 2014K132451SARNS SOFT-FLOW AORTIC CANNULA
Terumo Cardiovascular Systems Corp.
DWF
Feb 3, 2014K133151SARNS HIGH FLOW AORTIC ARCH CANNULA
Terumo Cardiovascular Systems Corp.
DWF
Sep 27, 2013K131618LARGE (6) ROLLER PUMP FOR TERUMO ADVANCED PERFUSION SYSTEM 1; LARGE (6) ROLLER PUMP FOR TERUMO ADVANCED PERFUSION SYST
Terumo Cardiovascular Systems Corporation
DWB
Mar 13, 2013K130359CAPIOX SX18 HOLLOW FIBER OXYGENATOR WITH DETACHABLE HARDSHELL RESERVOIR, CAPIOX SX25 HOLLOW FIBER OXGENATOR WITH DETACHA
Terumo Cardiovascular Systems Corp.
DTZ
Mar 13, 2013K130333CAPIX RX HOLLOW FIBER OXYGENATOR WITH/WITHOUT HARDSHELL RESERVOIR
Terumo Cardiovascular Systems Corp.
DTZ
Nov 20, 2012K123039CDI BLOOD PARAMETER MONITORING SYSTEM 500
Terumo Cardiovascular Systems Corp.
DRY
May 8, 2012K121209TERUMO PALL AL20X ARTERIAL FILTER
Terumo Cardiovascular Systems Corporation
DTM
Feb 7, 2012K113214TLINK DATA MANAGEMENT SYSTEM (DMS)
Terumo Cardiovascular Systems Corp.
DXJ
Dec 19, 2011K112587ADVANCED PERFUSION SYSTEM 1 (APS1) TUBE CLAMP ASSEMBLY, ROLLER PUMP 6 INCH CLASSIC COLOR,
Terumo Cardiovascular Systems Corp.
DWB
Dec 9, 2011K112229SARN CENTRIFUGAL PUMP
Terumo Cardiovascular Systems
KFM
May 19, 2010K093992TERUMO LAUER LOCK ADAPTER
Terumo Cardiovascular Systems Corporation
DTL
May 12, 2010K092789VIRTUOSAPH PLUS ENDOSCOPIC VESSEL HARVESTING SYSTEM
Terumo Cardiovascular Systems Corp.
GCJ
Dec 10, 2009K092644TERUMO PRESSURE ISOLATOR
Terumo Cardiovascular Systems Corp.
DRS
Aug 20, 2009K083747TERUMO PALL AL3X ARTERIAL FILTER
Terumo Cardiovascular Systems Corp.
DTM
Jun 8, 2009K090698CAPIOX BUBBLE TRAP WITH X-COATING
Terumo Cardiovascular Systems
KRL
Apr 17, 2009K083834TERUMO PALL AL6X ARTERIAL FILTER
Terumo Cardiovascular Systems Corp.
DTM
Apr 3, 2009K090878MODIFICATION TO TERUMO'S TENDERFLOW PEDIATRIC VENOUS RETURN CANNULAE (X-COATING)
Terumo Cardiovascular Systems Corp.
DWF
Feb 13, 2009K082321TERUMO ROCSAFE HYBRID PERFUSION SYSTEM
Terumo Cardiovascular Systems Corp.
KFM
Jan 16, 2009K083194VIRTUOSAPH (TM) ENDOSCOPIC VEIN HARVESTING DISPOSABLE SYSTEM, MODEL MCVS550
Terumo Cardiovascular Systems Corp.
GCJ
Dec 18, 2008K083301X-COATED TERUMO AND SARNS DUAL STAGE VENOUS RETURN CATHETERS, SARNS MALLEABLE VENOUS AND DUAL STAGE RETURN CATHETERS
Terumo Cardiovascular Systems Corp.
DWF
Jun 17, 2008K080034THREE STAGE VENOUS RETURN CANNULA, MODEL 816460
Terumo Cardiovascular Systems Corp.
DWF
Apr 17, 2008K080774CAPIOX SP PUMP (WITH OR WITHOUT X-COATING)
Terumo Cardiovascular Systems Corp.
KFM
Nov 21, 2007K071521TERUMO HX2 TEMPERATURE MANAGEMENT SYSTEM
Terumo Cardiovascular Systems Corp.
DWC
Apr 24, 2007K070839MODIFICATION TO CAPIOX FLEXIBLE VENOUS RESERVOIR
Terumo Cardiovascular Systems Corp.
DTN
Mar 13, 2007K063618TENDERFLOW PERIATRIC ARTERIAL CANNULA
Terumo Cardiovascular Systems Corp.
DWF

Newest 50 of 74.

Latest recalls

DateFirm and productCodeLinked 510(k)
Jun 24, 2025Terumo Cardiovascular Systems Corporation
CDI OneView System BPM Probe: Cat. No. CDI753 - CDI OneView BPM Probe, Cat. No. CDI753TK - CDI OneView BPM Probe Trial Kit
Open, Classified
DRYK234065
Mar 31, 2025Terumo Cardiovascular Systems Corporation
Terumo CDI OneView Monitoring System Hematocrit / Oxygen Saturation Probe, Catalog Number REF CD1754
Open, Classified
DRYK234065
Mar 29, 2024Terumo Cardiovascular Systems Corporation
Cardiovascular Procedure Kits that include High Crack Check Valve PN 205307A Part Number: 6375 16010 62974 65246 66312 66342 66388 66650 66852 70472 74307 74365 74366 74430 74475 74477 74502 74773 748
Open, Classified
OEZNone listed
Apr 5, 2023Terumo Cardiovascular Systems Corporation
CAPIOX FX25 Hollow Fiber Oxygenator, Catalog Numbers 3CX*FX25REC, 3CX*FX25RWC
Open, Classified
DTZK151791
Apr 5, 2023Terumo Cardiovascular Systems Corporation
CAPIOX NX19 Hollow Fiber Oxygenator, Catalog Number 3CX*NX19RE
Open, Classified
DTZK180950
Apr 5, 2023Terumo Cardiovascular Systems Corporation
CAPIOX RX15 Hollow Fiber Oxygenator, Catalog Number 3CX*RX15RE30
Open, Classified
DTZK062381
Feb 3, 2022Terumo Cardiovascular Systems Corp
Cardiovascular Procedure Kit catalog # 76645 & 73806
Terminated
OEZNone listed
Jun 8, 2021Terumo Cardiovascular Systems Corporation
Terumo Advanced Perfusion System 1 Electronic Patient Gas System Catalog #: 801188
Terminated
DTQK172220
Apr 16, 2021Terumo Cardiovascular Systems Corporation
The Sarns TCM II (system) is a source of temperature-controlled water for blood heat exchangers used in an extracorporeal circuit and for blankets to externally heat or cool the patient. It also freez
Terminated
DWCK883603
Apr 16, 2021Terumo Cardiovascular Systems Corporation
The Sarns Temperature Control and Monitor unit (TCM) is a source of temperature-controlled water for blood heat exchangers used in an extracorporeal circuit and for blankets to externally heat or cool
Terminated
DWCK841402
Apr 16, 2021Terumo Cardiovascular Systems Corporation
The Terumo HX2 Temperature Management System provides temperature control of two independent water circuits that directly controls the temperature of patient blood and cardioplegia solution during car
Terminated
DWCK071521
Mar 2, 2021Terumo Cardiovascular Systems Corporation
Consist of a distal connection mechanism (either standard Terumo Ball Quick Connect or Terumo Shaft Quick Connect), an articulating arm with links, a handle for providing cable tension, and a mechanis
Terminated
MWSNone listed
Nov 11, 2020Terumo Cardiovascular Systems Corporation
(1) Capiox FX25 (West) Advance Oxygenator- with left port, 4-liter Reservoir, XC modified to Advance, Sterile Catalog Number: 3CX*FX25RWC (2) Capiox FX25 (East) Advance Oxygenator - FX25 with right
Terminated
DTZK151791
Aug 25, 2020Terumo Cardiovascular Systems Corporation
Terumo Advanced Perfusion System 1 Ultrasonic Air Sensor 1/4x3/32, Catalog Number 5791 - Product Usage: intended for use with Terumo and Sarns brand air detection and heart-lung systems to detect gros
Terminated
DTQK172220
Aug 25, 2020Terumo Cardiovascular Systems Corporation
Terumo Advanced Perfusion System 1 Ultrasonic Air Sensor 1/4x1/16 UAS BLK, Catalog Number 5785 - Product Usage: intended for use with Terumo and Sarns brand air detection and heart-lung systems to det
Terminated
DTQK172220
Aug 25, 2020Terumo Cardiovascular Systems Corporation
Terumo Advanced Perfusion System 1 Ultrasonic Air Sensor 3/8x3/32, Catalog Number 5773 - Product Usage: intended for use with Terumo and Sarns brand air detection and heart-lung systems to detect gros
Terminated
DTQK172220
Jan 10, 2020Terumo Cardiovascular Systems Corporation
Terumo Advanced Perfusion Assembly Pump Guts, 4 Inch, Catalog Number 801805 - Product Usage: is indicated for use for up to 6 hours in the extracorporeal circulation of blood for arterial perfusion, r
Terminated
DTQK172220
Jan 10, 2020Terumo Cardiovascular Systems Corporation
Terumo Advanced Perfusion Assembly Pump Guts, 6 Inch, Catalog Number 801798 - is indicated for use for up to 6 hours in the extracorporeal circulation of blood for arterial perfusion, regional perfusi
Terminated
DTQK172220
Jan 10, 2020Terumo Cardiovascular Systems Corporation
Terumo Advanced Perfusion System 1 Roller Pump, 6 Inch, Catalog Number 816571 - Product Usage: is indicated for use for up to 6 hours in the extracorporeal circulation of blood for arterial perfusion,
Terminated
DTQK172220
Jan 10, 2020Terumo Cardiovascular Systems Corporation
Terumo Advanced Perfusion System 1 Roller Pump, 4 Inch, Catalog Number 816570 - Product Usage: is indicated for use for up to 6 hours in the extracorporeal circulation of blood for arterial perfusion,
Terminated
DTQK172220
Jun 14, 2019Terumo Cardiovascular Systems Corporation
Terumo Capiox NX19 Oxygenator (West Orientation P/N:CXOT281 Exported only to Japan for inclusion into convenience kits that are sold only within the Japanese market
Terminated
DTZK180950
Jun 14, 2019Terumo Cardiovascular Systems Corporation
Terumo Capiox NX19 Oxygenator (East Orientation), P/N: CXOT280 Exported only to Japan for inclusion into convenience kits that are sold only within the Japanese market
Terminated
DTZK180950
Jun 14, 2019Terumo Cardiovascular Systems Corporation
Terumo Capiox NX19 Oxygenator With Reservoir (West Orientation) P/N: 3CX*NX19RW
Terminated
DTZK180950
Jun 14, 2019Terumo Cardiovascular Systems Corporation
Terumo Capiox NX19 Oxygenator With Reservoir (East Orientation) P/N: 3CX*NX19RE
Terminated
DTZK180950
Apr 18, 2019Terumo Cardiovascular Systems Corporation
Terumo Advanced Perfusion System 1 Electronic Patient Gas System, Catalog # 801188, UDI 00886799000588 The electronic gas blender provides control and monitoring of the gas flow rate and oxygen conte
Terminated
DTQK172220
Dec 20, 2018Terumo Cardiovascular Systems Corporation
Cardiovascular Procedure Kit (CLR MP4 COIL 2 SPIKE) Catalog Number: 140222
Terminated
OEZNone listed
Oct 17, 2018Terumo Cardiovascular Systems Corporation
Terumo Advanced Perfusion System 1 Electronic Patient Gas System (EPGS), Electronic Gas Blender, Catalog #: 801188, UDI 00886799000588. Used in cardio-pulmonary bypass.
Terminated
DTQK172220
Sep 13, 2018Terumo Cardiovascular Systems Corporation
Terumo Advanced Perfusion System 1 Electronic Patient Gas System, Catalog#: 801188
Terminated
DTQK172220
Aug 31, 2018Terumo Cardiovascular Systems Corporation
VirtuoSaph Plus Endoscopic Vessel Harvesting System, Catalog Number: VSP550EX Product Usage: The VittuoSaph Plus Endoscopic Vessel Harvesting System VSP550EX is indicated for use in minimally invasiv
Terminated
GEIK140008
Aug 28, 2018Terumo Cardiovascular Systems Corporation
Terumo 220/240V AC, Advanced Perfusion System Platform (APS) for use in cardiopulmonary bypass procedures. Catalog Number 801764
Terminated
DTQK172220
Aug 28, 2018Terumo Cardiovascular Systems Corporation
Terumo 100/120V AC, Advanced Perfusion System Platform (APS) for use in cardiopulmonary bypass procedures. Catalog Number 801763
Terminated
DTQK172220
Jun 26, 2018Terumo Cardiovascular Systems Corporation
Monitor with one Blood Parameter Module and one HSat Probe; 500AHCT Monitor with two Blood Parameter modules and one HSat Probe; 500AVHCT Product Usage: The CDI System 500 provides continuous, on-lin
Terminated
DRYK133658
Jun 26, 2018Terumo Cardiovascular Systems Corporation
CDI Blood parameter monitoring system 500 H/SAT, Part No. 145883 Product Usage: The CDI System 500 provides continuous, on-line monitoring of the extracorporeal partial pressure of oxygen and carbon
Terminated
DRYK133658
Apr 18, 2018Terumo Cardiovascular Systems Corporation
Sarns TCM II, Catalog Numbers: 4415; 4416;164925; 164930;164935;164940 UDI 00886799000014 The Sarns TCM is indicated for controlling and monitoring patient temperature .
Terminated
DWCK883603
Apr 18, 2018Terumo Cardiovascular Systems Corporation
Sarns TCM, Catalog No. 15747 The Sarns TCM is indicated for controlling and monitoring patient temperature .
Terminated
DWCK841402
Apr 18, 2018Terumo Cardiovascular Systems Corporation
Terumo HX2 Temperature Management System, Catalog No. 809810 The Terumo HX2 Temperature Management System is indicated for use to supply temperature regulated water to heat exchangers during open hea
Terminated
DWCK071521
Jan 19, 2018Terumo Cardiovascular Systems Corporation
Flowmeter Module (accessory to Terumo Advanced Perfusion System 1). Provides the interface between the flow sensor and the system.
Terminated
DTQK172220
Dec 18, 2017Terumo Cardiovascular Systems Corp
Terumo Cardiovascular Procedure Kits containing Pall LG6NS LeukoGuard Leukocyte Reduction Arterial Blood Filters. The Cardiovascular Procedure Kit containing the Pall LG6NS LeukoGuard Leukocyte Reduc
Terminated
OEZNone listed
Jun 27, 2017Terumo Cardiovascular Systems Corporation
Custom surgical kits containing TERUMO(R) Overpressure Safety Valve, REF: (a) LH130 and (b) LH130J Catalog numbers: US distribution: LH130 74369 71156
Terminated
DTLK820297
Jun 27, 2017Terumo Cardiovascular Systems Corporation
TERUMO(R) Overpressure Safety Valve, REF: (a) LH130 (b) LH130J
Terminated
DTLK820297
May 12, 2017Terumo Cardiovascular Systems Corp
Tubing Pack Convenience Kit, Product Code 65217 Product Usage: Intended for use only in the extracorporeal circuit of the cardiopulmonary bypass procedures for which the user designed it.
Terminated
OEZNone listed
Mar 14, 2017Terumo Cardiovascular Systems Corporation
Terumo Advanced Perfusion System 1-Level Sensor II Gel Pads Product Usage: Level sensor pads are used to attach the level sensors to a hard shell reservoir. includes coupling gel.
Terminated
DTQK153376
Mar 14, 2017Terumo Cardiovascular Systems Corporation
Terumo Advanced Perfusion System 1-Level Sensor II Pads, Product Usage: Ultrasonic couplant used to facilitate the transmission of sound energy between the level sensor and the reservoir.
Terminated
DTQK153376
Feb 22, 2017Terumo Cardiovascular Systems Corporation
The Sarns Centrifugal Pump is a single use device sterilized by ethylene oxide gas. The device is sold single sterile in cartons of 8 units, or may be provided in bulk, non-sterile to another Teru
Terminated
KFMK112229
Feb 22, 2017Terumo Cardiovascular Systems Corporation
Titan" Stabilizer Attachment and Titan TM 360 Stabilizer Attachment
Terminated
MWSNone listed
Feb 14, 2017Terumo Cardiovascular Systems Corporation
Hercules 360 Universal Stabilizing Arm, top mount, 360-degree rotation, reusable stainless steel
Terminated
MWSNone listed
Jul 25, 2016Terumo Cardiovascular Systems Corp
Terumo Custom Cardiovascular System Cardiovascular Procedure Kits labeled containing Coated Tubing as follows: This product is intended for use only in the extracorporeal circuit for the cardiopulm
Terminated
OEZNone listed
Jul 14, 2016Terumo Cardiovascular Systems Corporation
Preamendments device-Sarns Dual Cooler-Heater. The Sarns Dual Cooler-Heater is a self-contained unit for supplying cold and warm water to heat exchangers during open heart surgery. It supplies wat
Terminated
DWCNone listed
Jul 14, 2016Terumo Cardiovascular Systems Corporation
Sarns TCM II; The Sarns Temperature Control and Monitor unit (TCM) II (system) is a source of temperature controlled water for blood heat exchangers used in an extracorporeal circuit and for blanket
Terminated
DWCK883603
Jul 14, 2016Terumo Cardiovascular Systems Corporation
Sarns TCM; The Sarns Temperature Control and Monitor unit (TCM) is a source of temperature-controlled water for blood heat exchangers used in an extracorporeal circuit and for blankets to externally
Terminated
DWCK841402

Newest 50 of 571.

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