ClearanceBrief
Panels › Cardiovascular › Product code DTQ · Class 2

Console, Heart-Lung Machine, Cardiopulmonary Bypass

Regulation 870.4220

0510(k)s in 12 months (52 all time)
1recalls in 12 months (267 all time)
257recalls that name a 510(k)
Get daily alerts for DTQSample briefCSV

Top companies in DTQ

DateFirm and productCodeLinked 510(k)
Feb 5, 2026Maquet Cardiopulmonary Gmbh
Bubble Sensor for 3/8" x 3/32" tubing; Model Number: 701055720;
Open, Classified
DTQK133598
May 27, 2025Maquet Cardiopulmonary Ag
Cardiohelp System HKH 8820 Wall Holder. Mounting bracket designed to hold the CARDIOHELP-i system for interhospital transport by vehicle.
Open, Classified
DTQK102726
Nov 27, 2024LivaNova Deutschland GmbH
Essenz HLM (Heart-Lung Machine), REF: 49-00-10, with Software
Open, Classified
DTQK232291
Oct 24, 2024Spectrum Medical Ltd.
Quantum Perfusion Systems for CPB, Roller Pumps use peristaltic action to propel blood through the venous and arterial circuit tubing. Catalog Numbers: a) 51-000013-00, b) 51-000008-00
Completed
DTQK173834
Sep 30, 2024Maquet Medical Systems USA
CARDIOHELP-i Heart Lung Support System: Blood oxygenation and carbon dioxide removal system used to pump blood through the extracorporeal bypass circuit for circulatory and/or pulmonary support for pe
Open, Classified
DTQK133598
May 16, 2024Maquet Medical Systems USA
CARDIOHELP-i System. Blood oxygenation and carbon dioxide removal system.
Open, Classified
DTQK133598
Feb 8, 2024Maquet Medical Systems USA
Bubble Sensor (REF: 70105.5720)
Open, Classified
DTQK133598
Dec 21, 2023Maquet Medical Systems USA
Venous probe connection cable (REF 701069333 and 701048804) used with the Cardiohelp-i System, part numbers 701072780 and 701041802
Open, Classified
DTQK133598
Dec 14, 2023Maquet Medical Systems USA
CARDIOHELP-i Heart Lung Support System- A blood oxygenation and carbon dioxide removal system used to pump blood through the extracorporeal bypass circuit for circulatory and/or pulmonary support for
Open, Classified
DTQK133598
Dec 7, 2023Maquet Medical Systems USA
CARDIOHELP Emergency Drive, Part Numbers 701048002 and 701076205. The CARDIOHELP System is a blood oxygenation and carbon dioxide removal system.
Open, Classified
DTQK133598
Nov 9, 2023Maquet Medical Systems USA
Cardiohelp-i, blood oxygenation and carbon dioxide removal system, Part Numbers 701072780 (Cardiohelp-i), 701068550 (Slide Rail Holder)
Open, Classified
DTQK133598
May 26, 2023Maquet Medical Systems USA
QUADROX-iR, used during cardiopulmonary bypass Model Item No. Description BEQ-HMO 51100-USA 701067936 Small Adult with filter, with BIOLINE Coating BE
Open, Classified
DTQK102726
Feb 18, 2022Maquet Medical Systems USA
Cardiohelp-i Transport Guard with Transport Guard (701072525): is a blood oxygenation and carbon dioxide removal system used to pump blood through the extracorporeal bypass circuit for circulatory a
Open, Classified
DTQK133598
Jun 8, 2021Terumo Cardiovascular Systems Corporation
Terumo Advanced Perfusion System 1 Electronic Patient Gas System Catalog #: 801188
Terminated
DTQK172220
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
Aug 23, 2019Spectrum Medical Ltd.
Quantum Pump Console
Terminated
DTQK173834
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
Mar 28, 2019Maquet Cardiovascular Us Sales, Llc
Cardiohelp Emergency Drive, Part No. 70104.8002 Product Usage: The Cardiohelp Emergency Drive is used in emergencies to manually drive the disposable if the Cardiohelp-i fails.
Terminated
DTQK102726
Jan 28, 2019LivaNova USA Inc.
LivaNova Sorin Connect DPIII KOMPL. S5 REF 96-415-130, 2017-08-15, IPX1, RXOnly, (01)04033817901594 Product Usage: The S5 System is used to perform, control and monitor extracorporeal blood circulat
Terminated
DTQK071318
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 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
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
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
Sep 21, 2016Sorin Group USA, Inc.
Stckert S5 System, S5 Heart-lung machine, Cardiopulmonary bypass heart-lung machine console Product Usage: The Stckert S5 System is intended to be used during cardiopulmonary bypass for procedures la
Terminated
DTQK071318
Feb 23, 2016Maquet Cardiovascular Us Sales, Llc
HLS Set Advanced with BIOLINE Coating Custom tubing packs for the oxygenator
Terminated
DTQK102726
May 28, 2015Terumo Cardiovascular Systems Corporation
Base for Terumo Advanced Perfusion System 1, 220/240V The Terumo Advanced Perfusion System 1 is indicated for use for up to 6 hours on the extracorporeal circulation of blood for arterial perfusion, r
Terminated
DTQK022947
May 28, 2015Maquet Cardiovascular Us Sales, Llc
HLS/HIT Set Advanced with Bioline and/or Softline Coating Console Product Usage: HLS/HIT Set Advanced: The CARDIO HELP System in configuration with the HLS/HIT Set Advanced is intended to be used wi
Terminated
DTQK102726
May 28, 2015Terumo Cardiovascular Systems Corporation
100/120V AC, Advanced Perfusion System Platform (APS) The Terumo Advanced Perfusion System 1 is indicated for use for up to 6 hours on the extracorporeal circulation of blood for arterial perfusion, r
Terminated
DTQK022947
Nov 13, 2014Maquet Cardiovascular Us Sales, Llc
Cardiohelp-I System Product Usage: A blood oxygenation and carbon dioxide removal system used to pump blood thorough the extracorporeal bypass circuit for circulatory and/or pulmonary support durin
Terminated
DTQK102726
Jul 8, 2014Terumo Cardiovascular Systems Corporation
Terumo Advanced Perfusion System 1 220/240V AC, Advanced Perfusion System Platform (APS)
Terminated
DTQK022947
Jul 8, 2014Terumo Cardiovascular Systems Corporation
Terumo Advanced Perfusion System 1 100/120V AC, Advanced Perfusion System Platform (APS)
Terminated
DTQK022947
Jan 28, 2014Sorin Group Deutschland GmbH
S5/C5 Heart-lung machine Product Usage: The StOckert S5/ Sorin C5 System is intended to be used during cardiopulmonary bypass for procedures lasting six (6) hours or less.
Terminated
DTQK071318
K093882
Nov 4, 2013Sorin Group Deutschland GmbH
S5 Heart-lung machine, Stockert S5 System. Catalogue No: 48-30/40/50-00. The Stockert S5 System is intended to be used during cardiopulmonary bypass for procedures lasting six(6) hours or less.
Terminated
DTQK071318
Oct 25, 2013Maquet Medical Systems USA
MAQUET Getinge Group CARDIOHELP Base Unit REF 70104.7999 REF 70104.8012 Manufactured for: MAQUET Cardiopulmonary AG Made in Germany. Cardiopulmonary support system.
Terminated
DTQK102726
Aug 15, 2013Terumo Cardiovascular Systems Corporation
220/240V AC, Advanced Perfusion System 1 Product Usage: The Terumo Advanced Perfusion System 1 is indicated for use in extracorporeal circulation of blood for arterial perfusion, regional perfusion,
Terminated
DTQK022947
Aug 15, 2013Terumo Cardiovascular Systems Corporation
100/120V AC, Advanced Perfusion System 1 Product Usage: The Terumo Advanced Perfusion System 1 is indicated for use in extracorporeal circulation of blood for arterial perfusion, regional perfusion,
Terminated
DTQK022947
Aug 14, 2013Terumo Cardiovascular Systems Corporation
Terumo Advanced Perfusion System 1 (APS1, System 1) Description: 220/240V AC Product Usage: The Terumo Advanced Perfusion System 1 is indicated for use in extracorporeal circulation of blood for arte
Terminated
DTQK022947
Aug 14, 2013Terumo Cardiovascular Systems Corporation
Terumo Advanced Perfusion System 1 (APS1, System 1) 100/120V AC Product Usage: The Terumo Advanced Perfusion System 1 is indicated for use in extracorporeal circulation of blood for arterial perfusio
Terminated
DTQK022947
Aug 14, 2013Terumo Cardiovascular Systems Corporation
Terumo Advanced Perfusion System 1: 220/240V AC, Advanced Perfusion System 1 The Terumo Advanced Perfusion System 1 is indicated for use in extracorporeal circulation of blood for arterial perfusion
Terminated
DTQK022947
Aug 14, 2013Terumo Cardiovascular Systems Corporation
Terumo Advanced Perfusion System 1: 100/120V AC, Advanced Perfusion System 1 The Terumo Advanced Perfusion System 1 is indicated for use in extracorporeal circulation of blood for arterial perfusion,
Terminated
DTQK022947
Apr 18, 2013Maquet Cardiovascular, LLC
MAQUET CARDIOHELP Support System: CARDIOHELP-I Software (up to version 3.3.0.0) Product Usage: The Cardiohelp System is a blood oxygenation and carbon dioxide removal system used to pump blood thro
Terminated
DTQK102726

Free CSV: newest 100 rows. Paid plans export up to 1,000 or 10,000 rows.