ClearanceBrief
Company ยท US

Datascope Corp.

FDA 510(k) clearances and medical device recalls filed under this name, 1976 to 2019. Name variants (Inc, Corp, punctuation) are merged.

136510(k) clearances (0 in 12 months)
155recalls (7 in 12 months)
138recalls that name a 510(k)

Product codes

CodeDeviceRecords
DSPSystem, Balloon, Intra-Aortic And Control165
DTNReservoir, Blood, Cardiopulmonary Bypass22
DWETubing, Pump, Cardiopulmonary Bypass14
DRTMonitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)12
DQXWire, Guide, Catheter10
MHXMonitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)7
DYBIntroducer, Catheter6
DXNSystem, Measurement, Blood-Pressure, Non-Invasive4
CCKAnalyzer, Gas, Carbon-Dioxide, Gaseous-Phase3
DSIDetector And Alarm, Arrhythmia3
GEIElectrosurgical, Cutting & Coagulation & Accessories3
MWIMonitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)3
BSZGas-Machine, Anesthesia2
CBQAnalyzer, Gas, Enflurane, Gaseous-Phase (Anesthetic Concentration)2
DQAOximeter2
DSFRecorder, Paper Chart2
DXGComputer, Diagnostic, Pre-Programmed, Single-Function2
LDDDc-Defibrillator, Low-Energy, (Including Paddles)2
BZKSpirometer, Monitoring (W/Wo Alarm)1
CBSAnalyzer, Gas, Halothane, Gaseous-Phase (Anesthetic Conc.)1

Latest 510(k) clearances

Decided510(k)Device and applicantCode
Dec 26, 2019K190884TigerPaw Pro Left Atrial Appendage Occlusion Fastener And Delivery Tool
Datascope Corp.
GDW
May 31, 2018K181122CARDIOSAVE Intra-Aortic Balloon Pump
Datascope Corp.
DSP
Oct 12, 2017K172305CS100/CS100i Intra-Aortic Balloon Pump, CS300 Intra-Aortic Balloon Pump
Datascope Corp.
DSP
Jan 31, 2017K163542CARDIOSAVE Hybrid and Rescue Intra-Aortic Balloon Pump, CARDIOSAVE Li-Ion Battery Transport and Storage Case
Datascope Corp.
DSP
Jul 2, 2015K151254CARDIOSAVE Hybrid Intra-Aortic Balloon Pump
Datascope Corp.
DSP
Dec 12, 2013K133074MEGA 8FR. 50CC AND SENSATION PLUS 8FR. 50CC INTRA-AORTIC BALLOON CATHETERS AND ACCESSORIES
Datascope Corp.
DSP
Sep 25, 2007K071805NETGUARD AUTOMATED CLINICIAN ALERT SYSTEM, MODEL 0998-00-1600-XX
Datascope Corp.
DSI
Feb 14, 2007K062569SAFEGUARD 24 CM PRESSURE ASSISTED DRESSING
Datascope Corp.
DXC
Feb 5, 2007K062098SPECTRUM MONITOR, MODEL 0998-00-1000-XXXXX
Datascope Corp.
MHX
Jan 5, 2007K063525DATASCOPE FIBER OPTIC PRESSURE SENSOR INTRA-AORTIC BALLOON CATHETER AND CS300 INTRA-AORTIC BALLOON PUMP CONTROL SYSTEM
Datascope Corp.
DSP
Nov 2, 2006K062754GAS MODULE SE, MODEL 0998-00-0481-02
Datascope Corp.
BZK
Aug 12, 2005K051897TRIO MONITOR
Datascope Corp.
MWI
Sep 23, 2004K042016DATASCOPE PROGUIDE CHRONIC DIALYSIS CATHETER
Datascope Corp.
MSD
Jul 23, 2004K041907TRIO MONITOR
Datascope Corp.
MWI
Jun 7, 2004K041281DATASCOPE 7.5FR. IAB CATHETER AND ACCESSORIES
Datascope Corp.
DSP
Feb 11, 2004K032338TRIO MONITOR MODEL 0998-00-0600
Datascope Corp.
MWI
Oct 10, 2003K031760VIEWPOINT TELEMETRY SYSTEM
Datascope Corp.
MHX
Sep 9, 2003K031849SPECTRUM PATIENT MONITOR, MODEL 0998-00-0500-XXXXX
Datascope Corp.
MHX
Aug 11, 2003K031636CS100 INTRA-AORTIC BALLOON PUMP, MODEL 0998-00-3013-XX
Datascope Corp.
DSP
Jun 10, 2003K031569DATASCOPE CA 40 8FR. IABS, MODEL 0684-00-04XX
Datascope Corp.
DSP
Aug 28, 2002K020550PASSPORT 2 WITH VIEW 12 ECG ANALYSIS MODULE MODEL # 0998-00-0170-XXXX
Datascope Corp.
DSI
Apr 24, 2002K020257DATASCOPE'S 8FR. ALT B IAB; DATASCOPE'S PROFILE 8FR. ALT B IAB; DATASCOPE'S TRUE SHEATHLESS DL 9.5 FR. IAB; DATASCOPE'S
Datascope Corp.
DSP
Feb 6, 2002K011540VIEWPOINT CENTRAL MONITORING SYSTEM, MODEL 0998-00-0187-07
Datascope Corp.
MHX
Nov 2, 2001K013326MODIFICATION TO: DATASCOPE 8FR. POLYIMIDE ALT B IAB, 25CC, 34CC, 40CC, DATASCOPE INSERTION KIT FOR 8 FR, POLYIMIDE ALT B
Datascope Corp.
DSP
Dec 21, 2000K003598DATASCOPE PROFILE 8FR. ALT B IAB, 34CC, DATASCOPE PROFILE 8FR. ALT B IAB, 40CC, MODEL 0684-000319, 0684-00-0320
Datascope Corp.
DSP
Oct 20, 2000K002949MODIFICATION TO DATASCOPE PROFILE 8FR. IAB, 34CC; MODIFICATION TO DATASCOPE PROFILE 8FR. IAB, 40CC
Datascope Corp.
DSP
Aug 25, 2000K002365DATASCOPE REINFORCED PERCUTANEOUS CATHETER INTRODUCER SET
Datascope Corp.
DYB
May 12, 2000K001198DATASCOPE NITINOL CATHETER GUIDE WIRE (145 CM), DATASCOPE NITINOL CATHETER GUIDE WIRE (175 CM), DATASCOPE NITINOL CATHET
Datascope Corp.
DQX
Mar 13, 2000K994157DATASCOPE'S 8FR. POLYMIDE 25CC,34CC AND 40CC IAB AND ACCESSORIES, MODELS 0684-00-0327, 06844-00-0328, 0684-00-0329
Datascope Corp.
DSP
Jan 13, 2000K993531PASSPORT 2 VITAL SIGNS MONITOR, MODEL 0998-00-0170-XX
Datascope Corp.
DSI
May 13, 1999K983575ACCUTORR PLUS NON INVASIVE BLOOD PRESSURE MONITOR, MODEL # 0998-00-0117-XX
Datascope Corp.
DXN
Jun 26, 1998K974178PASSPORT 5L-CE MODEL 0998-00-0131XXX
Datascope Corp.
DRT
May 29, 1998K980780DATASCOPE PERCOR STAT-DL 9.5 FR. 25, 34 AND 40CC INTRA-AORIC BALLOONS WITH ALTERNATE B MEMBRANE FOR OPTIONAL SHEATHLES
Datascope Corp.
DSP
May 1, 1998K980385DATASCOPE 8FR. CO-LUMEN 34 AND 40CC INTRA-AORTIC BALLOON CATHETERS FOR OPTIONAL SHEATHLESS INSERTION WITH ACCESSORIES
Datascope Corp.
DSP
Mar 13, 1998K974903GAS MODULE II, MODEL 0998-00-0143
Datascope Corp.
CBS
Nov 6, 1997K973007DATASCOPE'S 10 FR. FLEXISHEATH PERCUTANEOUS INTRODUCER
Datascope Corp.
DYB
Sep 25, 1997K970061ACCUTORR PLUS NON INVASIVE BLOOD PRESSURE MONITOR (0998-00-0117-XX)
Datascope Corp.
DQA
Jul 1, 1997K965236SYSTEM 96 INTRA-AORTIC BALLOON PUMP (IABP)
Datascope Corp.
DSP
Mar 17, 1997K964987DATASCOPE PERCOR STAT - DL 9.5 FR. 25 AND 40CC INTRA-AORTIC BALLOON FOR OPTIONAL SHEATHLESS INSERTION AND PERCOR STAT -0
Datascope Corp.
DSP
Nov 15, 1996K961509INTRA-AORTIC BALLOON PUMP SYSTEM 97 MODIFIED
Datascope Corp.
DSP
Apr 24, 1996K960166PERCOR STAT-DL 9.5 FR. 34 & 40CC
Datascope Corp.
DSP
Dec 22, 1995K943896GUIDE WIRE FOR THE USE WITH DATASCOPE PERCOR STAT-DL IABS
Datascope Corp.
DQX
Feb 24, 1995K942454DATASCOPE 95 AND 97 IAB PUMP CONSOLE
Datascope Corp.
DSP
Dec 9, 1994K944460DATASCOPE INTRA-AORTIC BALLOON WITH MODIFIED STAT GARD
Datascope Corp.
DSP
Sep 13, 1994K940231INTRA-AORTIC BALLOON FOR OPTIONAL SHEATHLESS INSERTION
Datascope Corp.
DSP
Aug 9, 1994K940178PERCOR STAT-DL 9.5 FR.34CC & 40CC /PERCOR STAT-DL 10.5 FR.40CC & 50CC INTRA-AORTIC BALLOON MODIFICATION
Datascope Corp.
DSP
Aug 25, 1993K926451DATASCOPE MULTINEX II
Datascope Corp.
CBQ
Aug 25, 1993K914802DATASCOPE PERCOR STAT DL9.5 FR34CC INTRA-AORT BALL
Datascope Corp.
DSP
Aug 25, 1993K911000PERCOR STAT DL 8.5 FR 40CC INTRA-AORTIC BALLOON
Datascope Corp.
DSP
Aug 6, 1993K926099DATASCOPE 6000 MONITOR
Datascope Corp.
MLC

Newest 50 of 136.

Latest recalls

DateFirm and productCodeLinked 510(k)
Mar 19, 2026Datascope Corp.
Battery Charging Station; Model: 0998-00-0802;
Open, Classified
DSPK112372
Mar 3, 2026Datascope Corp.
CS300 IABP. Software Version CS300 IABP C.01.
Open, Classified
DSPK063525
K172305
Mar 3, 2026Datascope Corp.
CS100 IABP. Software Version CS100 IABP Q.01.
Open, Classified
DSPK031636
K172305
Dec 16, 2025Datascope Corp.
Cardiosave Rescue
Open, Classified
DSPK112372
K151254 +2
Dec 16, 2025Datascope Corp.
Cardiosave Hybrid
Open, Classified
DSPK112372
K151254 +2
Dec 11, 2025Datascope Corp.
Cardiosave Rescue. Intra-Aortic Balloon Pump system.
Open, Classified
DSPK163542
Dec 11, 2025Datascope Corp.
Cardiosave Hybrid. Intra-Aortic Balloon Pump system.
Open, Classified
DSPK112372
K151254 +1
Nov 5, 2024Datascope Corp.
MEGA 7.5Fr. 40cc Intra-Aortic Balloon with Accessories, Model Number 0684-00- 0295-01
Open, Classified
DSPK041281
K112327 +1
Sep 20, 2024Datascope Corp.
CARDIOSAVE RESCUE INTRA-AORTIC BALLOON PUMP (IABP). Electromechanical system used to inflate and deflate intra-aortic balloons.
Open, Classified
DSPK181122
Sep 20, 2024Datascope Corp.
CARDIOSAVE HYBRID INTRA-AORTIC BALLOON PUMP (IABP). Electromechanical system used to inflate and deflate intra-aortic balloons.
Open, Classified
DSPK181122
Sep 20, 2024Datascope Corp.
CARDIOSAVE RESCUE INTRA-AORTIC BALLOON PUMP (IABP). Electromechanical system used to inflate and deflate intra-aortic balloons.
Open, Classified
DSPK181122
Sep 20, 2024Datascope Corp.
CARDIOSAVE HYBRID INTRA-AORTIC BALLOON PUMP (IABP). Electromechanical system used to inflate and deflate intra-aortic balloons.
Open, Classified
DSPK181122
Aug 31, 2023Datascope Corp.
Cardiosave Rescue Intra-Aortic Balloon Pumps (IABP), Part Numbers 0998-00-0800-75, 0998-00-0800-83, 0998-00-0800-85
Open, Classified
DSPK181122
Aug 31, 2023Datascope Corp.
Cardiosave Hybrid Intra-Aortic Balloon Pumps (IABP), Part Numbers 0998-00-0800-31, 0998-UC-0800-31, 0998-00-0800-32, 0998-00-0800-33, 0998-UC-0800-33, 0998-00-0800-34, 0998-00-0800-35, 0998-00-0800-45
Open, Classified
DSPK181122
Aug 30, 2023Datascope Corp.
Cardiosave Rescue Intra-Aortic Balloon Pumps (IABP), Part Numbers 0998-00-0800-75, 0998-00-0800-83, 0998-00-0800-85
Open, Classified
DSPK181122
Aug 30, 2023Datascope Corp.
Cardiosave Hybrid Intra-Aortic Balloon Pumps (IABP), Part Numbers 0998-00-0800-31, 0998-UC-0800-31, 0998-00-0800-32, 0998-00-0800-33, 0998-UC-0800-33, 0998-00-0800-34, 0998-00-0800-35, 0998-00-0800-45
Open, Classified
DSPK181122
Aug 30, 2023Datascope Corp.
Cardiosave Rescue Intra-Aortic Balloon Pumps (IABP), Part Numbers 0998-00-0800-75, 0998-00-0800-83, 0998-00-0800-85, 0998-UC-0800-75, 0998-UC-0800-83, 0998-UC-0800-85,
Open, Classified
DSPK181122
Aug 30, 2023Datascope Corp.
Cardiosave Hybrid Intra-Aortic Balloon Pumps (IABP), Part Numbers 0998-00-0800-31, 0998-UC-0800-31, 0998-00-0800-32, 0998-00-0800-33, 0998-UC-0800-33, 0998-00-0800-34, 0998-00-0800-35, 0998-00-0800-45
Open, Classified
DSPK181122
Aug 30, 2023Datascope Corp.
Cardiosave Rescue Intra-Aortic Balloon Pumps (IABP), Part Numbers 0998-00-0800-75, 0998-00-0800-83, 0998-00-0800-85
Open, Classified
DSPK181122
Aug 30, 2023Datascope Corp.
Cardiosave Hybrid Intra-Aortic Balloon Pumps (IABP), Part Numbers 0998-00-0800-31, 0998-UC-0800-31, 0998-00-0800-32, 0998-00-0800-33, 0998-UC-0800-33, 0998-00-0800-34, 0998-00-0800-35, 0998-00-0800-45
Open, Classified
DSPK181122
Aug 30, 2023Datascope Corp.
Cardiosave Rescue Intra-Aortic Balloon Pumps (IABP), Part Numbers 0998-00-0800-75, 0998-00-0800-83, 0998-00-0800-85
Open, Classified
DSPK181122
Aug 30, 2023Datascope Corp.
Cardiosave Hybrid Intra-Aortic Balloon Pumps (IABP), Part Numbers 0998-00-0800-31, 0998-UC-0800-31, 0998-00-0800-32, 0998-00-0800-33, 0998-UC-0800-33, 0998-00-0800-34, 0998-00-0800-35, 0998-00-0800-45
Open, Classified
DSPK181122
Jul 21, 2023Datascope Corp.
REINFORCED INTRODUCER SET, Intra-Aortic Balloon Catheter and Accessories, used to provide counter pulsation therapy in the aorta Product Description
Open, Classified
DYBK002365
Jul 21, 2023Datascope Corp.
LINEAR 7.5Fr.IAB, Intra-Aortic Balloon Catheter and Accessories, used to provide counter pulsation therapy in the aorta Product Description
Open, Classified
DSPK041281
Jul 21, 2023Datascope Corp.
SENSATION PLUS 8Fr. IAB, Intra-Aortic Balloon Catheter and Accessories, used to provide counter pulsation therapy in the aorta Product Description
Open, Classified
DSPK133074
Jul 21, 2023Datascope Corp.
SENSATION PLUS 7.5Fr IAB, Intra-Aortic Balloon Catheter and Accessories, used to provide counter pulsation therapy in the aorta Product Description
Open, Classified
DSPK122628
Jul 21, 2023Datascope Corp.
MEGA 8Fr. IAB, Intra-Aortic Balloon Catheter and Accessories, used to provide counter pulsation therapy in the aorta Product Description
Open, Classified
DSPK133074
Jul 21, 2023Datascope Corp.
MEGA 7.5Fr.IAB , Intra-Aortic Balloon Catheter and Accessories, used to provide counter pulsation therapy in the aorta Product Description
Open, Classified
DSPK120868
Jul 21, 2023Datascope Corp.
TRANS-RAY IAB, Intra-Aortic Balloon Catheter and Accessories, used to provide counter pulsation therapy in the aorta Product Description Part Number
Open, Classified
DSPNone listed
Jul 21, 2023Datascope Corp.
SENSATION 7 Fr. IAB, Intra-Aortic Balloon Catheter and Accessories, used to provide counter pulsation therapy in the aorta Product Description
Open, Classified
DSPK063525
Jul 21, 2023Datascope Corp.
YAMATO PLUS IAB; intra-aortic balloon catheter and accessories used to provide counter pulsation therapy in the aorta. Product Description
Open, Classified
DSPNone listed
Jul 20, 2023Datascope Corp.
Cardiosave Rescue Intra-Aortic Balloon Pump (IABP), Model numbers 0998-00-0800-75 0998-00-0800-83 0998-00-0800-85
Open, Classified
DSPK181122
Jul 20, 2023Datascope Corp.
Cardiosave Hybrid Intra-Aortic Balloon Pump (IABP), Model numbers 0998-00-0800-31 0998-00-0800-32 0998-00-0800-33 0998-00-0800-34 0998-00-0800-35 0998-00-0800-45 0998-00-0800-52 0998-00-0800-53 0998-
Open, Classified
DSPK181122
Jul 19, 2023Datascope Corp.
Cardiosave Rescue Intra-Aortic Balloon Pump (IABP), Model numbers 0998-00-0800-75 0998-00-0800-83 0998-00-0800-85
Open, Classified
DSPK181122
Jul 19, 2023Datascope Corp.
Cardiosave Hybrid Intra-Aortic Balloon Pump (IABP), Model numbers 0998-00-0800-31 0998-00-0800-32 0998-00-0800-33 0998-00-0800-34 0998-00-0800-35 0998-00-0800-45 0998-00-0800-52 0998-00-0800-53 0998-
Open, Classified
DSPK181122
Jun 14, 2023Datascope Corp.
Cardiosave Hybrid Intra-Aortic Balloon Pumps (IABP), Model Number 0998-00-0800-55, Part Number 0998-00-0800-XX
Open, Classified
DSPK112372
Apr 26, 2023Datascope Corp.
MAQUET CARDIOSAVE hybrid Intra-Aortic Balloon Pump, Model Number 0998-XX-0800-32
Open, Classified
DSPK112372
Mar 22, 2023Datascope Corp.
Cardiosave Intra-Aortic Balloon Pump (IABP) Pneumatic Interface Module (PIM) , Model Number 0997-00-1178
Open, Classified
DSPK112372
Mar 22, 2023Datascope Corp.
Cardiosave Intra-Aortic Balloon Pump (IABP) Safety Disk, Model Number 0202-00-0140
Open, Classified
DSPK112372
Mar 22, 2023Datascope Corp.
Cardiosave Hybrid Intra-Aortic Balloon Pump (IABP), Model Numbers Model Numbers 0998-00-0800-75, 0998-00-0800-83, 0998-00-0800-85
Open, Classified
DSPK112372
Mar 22, 2023Datascope Corp.
Cardiosave Hybrid Intra-Aortic Balloon Pump (IABP), Model Numbers 0998-00-0800-31, 0998-00-0800-32, 0998-00-0800-33, 0998-00-0800-35, 0998-00-0800-45, 0998-00-0800-52, 0998-00-0800-53, 0998-00-0800-55
Open, Classified
DSPK112372
Mar 9, 2023Datascope Corp.
Cardiosave Rescue Model Nos. 0998-00-0800-75 0998-00-0800-83 0998-00-0800-85
Open, Classified
DSPK181122
Mar 9, 2023Datascope Corp.
Cardiosave Hybrid Model Nos. 0998-00-0800-31 0998-00-0800-32 0998-00-0800-33 0998-00-0800-34 0998-00-0800-35 0998-00-0800-45 0998-00-0800-52 0998-00-0800-53 0998-00-0800-55 0998-00-0800-65 0998-UC-0
Open, Classified
DSPK181122
Mar 9, 2023Datascope Corp.
Cardiosave Rescue Intra-Aortic Balloon Pumps (IABP), Containing Coiled Cord cable (part number 0012-00-1801, Model Numbers 0998-00-0800-75, 0998-00-0800-83, 0998-00-0800-85
Open, Classified
DSPK112372
Mar 9, 2023Datascope Corp.
Cardiosave Hybrid Intra-Aortic Balloon Pumps (IABP), Containing Coiled Cord cable (part number 0012-00-1801, Model Numbers 0998-00-0800-31, 0998-00-0800-32, 0998-00-0800-33, 0998-00-0800-34, 0998-00-0
Open, Classified
DSPK112372
Mar 6, 2023Datascope Corp.
Cardiosave Rescue Intra-Aortic Balloon Pump (IABP), Model Numbers 0998-00-0800-75, 0998-00-0800-83, and 0998-00-0800-85
Open, Classified
DSPK112372
Mar 6, 2023Datascope Corp.
Cardiosave Hybrid Intra-Aortic Balloon Pump (IABP), Model Numbers 0998-00-0800-31, 0998-00-0800-32, 0998-00-0800-33, 0998-00-0800-34, 0998-00-0800-35, 0998-00-0800-45, 0998-00-0800-52, 0998-00-0800-53
Open, Classified
DSPK112372
Mar 6, 2023Datascope Corp.
Cardiosave Rescue. Model Number: 0998-00-0800-83.
Open, Classified
DSPK181122
Mar 6, 2023Datascope Corp.
Cardiosave Hybrid Intra-Aortic Balloon Pump. Model Numbers: D998-00-0800-31, D998-00-0800-32, D998-00-0800-33, D998-00-0800-35, D998-00-0800-36, D998-00-0800-45, D998-00-0800-52, D998-00-0800-53, D998
Open, Classified
DSPK181122
Jan 19, 2023Datascope Corp.
Cardiosave Rescue Intra-Aortic Balloon Pump (IABP), Model Numbers 0998-00-0800-75, 0998-00-0800-83, 0998-00-0800-85, 0998-UC-0800-75, 0998-UC-0800-83, 0998-UC-0800-85.
Open, Classified
DSPK181122

Newest 50 of 155.

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