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)
Top companies in DTQ
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 5, 2026 | Maquet Cardiopulmonary Gmbh Bubble Sensor for 3/8" x 3/32" tubing;
Model Number: 701055720; Open, Classified |
DTQ | K133598 |
| May 27, 2025 | Maquet Cardiopulmonary Ag Cardiohelp System HKH 8820 Wall Holder. Mounting bracket designed to hold the CARDIOHELP-i system for interhospital transport by vehicle. Open, Classified |
DTQ | K102726 |
| Nov 27, 2024 | LivaNova Deutschland GmbH Essenz HLM (Heart-Lung Machine), REF: 49-00-10, with Software Open, Classified |
DTQ | K232291 |
| Oct 24, 2024 | Spectrum 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 |
DTQ | K173834 |
| Sep 30, 2024 | Maquet 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 |
DTQ | K133598 |
| May 16, 2024 | Maquet Medical Systems USA CARDIOHELP-i System. Blood oxygenation and carbon dioxide removal system. Open, Classified |
DTQ | K133598 |
| Feb 8, 2024 | Maquet Medical Systems USA Bubble Sensor (REF: 70105.5720) Open, Classified |
DTQ | K133598 |
| Dec 21, 2023 | Maquet Medical Systems USA Venous probe connection cable (REF 701069333 and 701048804) used with the Cardiohelp-i System, part numbers 701072780 and 701041802 Open, Classified |
DTQ | K133598 |
| Dec 14, 2023 | Maquet 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 |
DTQ | K133598 |
| Dec 7, 2023 | Maquet 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 |
DTQ | K133598 |
| Nov 9, 2023 | Maquet Medical Systems USA Cardiohelp-i, blood oxygenation and carbon dioxide removal system, Part Numbers 701072780 (Cardiohelp-i), 701068550 (Slide Rail Holder) Open, Classified |
DTQ | K133598 |
| May 26, 2023 | Maquet 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 |
DTQ | K102726 |
| Feb 18, 2022 | Maquet 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 |
DTQ | K133598 |
| Jun 8, 2021 | Terumo Cardiovascular Systems Corporation Terumo Advanced Perfusion System 1 Electronic Patient Gas System
Catalog #: 801188 Terminated |
DTQ | K172220 |
| Aug 25, 2020 | Terumo 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 |
DTQ | K172220 |
| Aug 25, 2020 | Terumo 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 |
DTQ | K172220 |
| Aug 25, 2020 | Terumo 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 |
DTQ | K172220 |
| Jan 10, 2020 | Terumo 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 |
DTQ | K172220 |
| Jan 10, 2020 | Terumo 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 |
DTQ | K172220 |
| Jan 10, 2020 | Terumo 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 |
DTQ | K172220 |
| Jan 10, 2020 | Terumo 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 |
DTQ | K172220 |
| Aug 23, 2019 | Spectrum Medical Ltd. Quantum Pump Console Terminated |
DTQ | K173834 |
| Apr 18, 2019 | Terumo 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 |
DTQ | K172220 |
| Mar 28, 2019 | Maquet 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 |
DTQ | K102726 |
| Jan 28, 2019 | LivaNova 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 |
DTQ | K071318 |
| Oct 17, 2018 | Terumo 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 |
DTQ | K172220 |
| Sep 13, 2018 | Terumo Cardiovascular Systems Corporation Terumo Advanced Perfusion System 1 Electronic Patient
Gas System, Catalog#: 801188 Terminated |
DTQ | K172220 |
| Aug 28, 2018 | Terumo Cardiovascular Systems Corporation Terumo 220/240V AC, Advanced Perfusion System Platform (APS) for use in cardiopulmonary bypass procedures.
Catalog Number 801764 Terminated |
DTQ | K172220 |
| Aug 28, 2018 | Terumo Cardiovascular Systems Corporation Terumo 100/120V AC, Advanced Perfusion System Platform (APS) for use in cardiopulmonary bypass procedures.
Catalog Number 801763 Terminated |
DTQ | K172220 |
| Jan 19, 2018 | Terumo Cardiovascular Systems Corporation Flowmeter Module (accessory to Terumo Advanced
Perfusion System 1).
Provides the interface between the flow sensor and the system. Terminated |
DTQ | K172220 |
| Mar 14, 2017 | Terumo 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 |
DTQ | K153376 |
| Mar 14, 2017 | Terumo 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 |
DTQ | K153376 |
| Sep 21, 2016 | Sorin 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 |
DTQ | K071318 |
| Feb 23, 2016 | Maquet Cardiovascular Us Sales, Llc HLS Set Advanced with BIOLINE Coating
Custom tubing packs for the oxygenator Terminated |
DTQ | K102726 |
| May 28, 2015 | Terumo 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 |
DTQ | K022947 |
| May 28, 2015 | Maquet 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 |
DTQ | K102726 |
| May 28, 2015 | Terumo 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 |
DTQ | K022947 |
| Nov 13, 2014 | Maquet 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 |
DTQ | K102726 |
| Jul 8, 2014 | Terumo Cardiovascular Systems Corporation Terumo Advanced Perfusion System 1
220/240V AC, Advanced Perfusion System
Platform (APS) Terminated |
DTQ | K022947 |
| Jul 8, 2014 | Terumo Cardiovascular Systems Corporation Terumo Advanced Perfusion System 1
100/120V AC, Advanced Perfusion System
Platform (APS) Terminated |
DTQ | K022947 |
| Jan 28, 2014 | Sorin 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 |
DTQ | K071318 K093882 |
| Nov 4, 2013 | Sorin 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 |
DTQ | K071318 |
| Oct 25, 2013 | Maquet 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 |
DTQ | K102726 |
| Aug 15, 2013 | Terumo 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 |
DTQ | K022947 |
| Aug 15, 2013 | Terumo 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 |
DTQ | K022947 |
| Aug 14, 2013 | Terumo 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 |
DTQ | K022947 |
| Aug 14, 2013 | Terumo 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 |
DTQ | K022947 |
| Aug 14, 2013 | Terumo 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 |
DTQ | K022947 |
| Aug 14, 2013 | Terumo 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 |
DTQ | K022947 |
| Apr 18, 2013 | Maquet 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 |
DTQ | K102726 |
Free CSV: newest 100 rows. Paid plans export up to 1,000 or 10,000 rows.