Product code DTQ
- Device name
- Console, Heart-Lung Machine, Cardiopulmonary Bypass
- Medical specialty
- Cardiovascular
- Device class
- 2
- Regulation number
- 870.4220
- Review panel
- CV
- Implant
- N
- Life sustaining/supporting
- Y
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K232291 | Essenz HLM, Essenz ILBM | Livanova Deutschland, GmbH | 2023-08-24 |
| K221895 | Terumo Advanced Perfusion System 1 | Terumo Cardiovascular Systems Corporation | 2023-04-18 |
| K221373 | Essenz HLM | Livanova Deutschland, GmbH | 2023-03-09 |
| K210130 | Stockert S5 System | Livanova Deutschland, GmbH | 2021-04-05 |
| K202125 | Century Perfusion System | Century Hlm, LLC | 2021-03-07 |
| K190282 | Quantum Smart Occluder LH (left-hand), Quantum Smart Occluder LH (right-hand) | Spectrum Medical , Ltd. | 2019-05-24 |
| K173834 | Quantum Pump Console | Spectrum Medical , Ltd. | 2018-05-25 |
| K172220 | Advanced Perfusion System 1 | Terumo Cardiovascular Systems Corporation | 2017-08-17 |
| K163531 | Advanced Perfusion System 1 | Terumo Cardiovascular Systems Corporation | 2017-06-07 |
| K153376 | Advanced Perfusion System 1 | Terumo Cardiovascular Systems Corporation | 2015-12-16 |
| K151349 | Advanced Perfusion System 1 | Terumo Cardiovascular Systems Corporation | 2015-08-27 |
| K133598 | CARDIOHELP SYSTEM | Maquet Cardiopulmonary, AG | 2014-05-21 |
| K131041 | ADVANCED PERFUSION SYSTEM 1 | Terumo Cardiovascular Systems Corp. | 2014-02-20 |
| K102726 | CARDIOHELP SYSTEM | Maquet Cardiopulmonary, AG | 2011-04-04 |
| K103762 | SORIN C5 SYSTEM; 85/C5 MAST ROLLER PUMP SYSTEM 150(1X RP 150 AND CONTROL PANEL WITH CONNECTING CABLES); S5/C5 MAST ROLLE | Sorin Group Deutschland GmbH | 2011-01-20 |
| K093882 | SORIN C5 SYSTEM MODEL 58-00-00 | Sorin Group Deutschland GmbH | 2010-01-15 |
| K092463 | SORIN B-CARE5 FOR THE STOCKERT S5 SYSTEM | Sorin Group Deutschland GmbH | 2009-11-05 |
| K090006 | LIFEBRIDGE B2T, MODEL 7001 | Lifebridge Medizintechnik AG | 2009-10-15 |
| K091007 | AIR PURGE CONTROL SYSTEM FOR S5 SYSTEM MODEL 23-45-05 | Sorin Group Deutschland GmbH | 2009-07-02 |
| K080832 | STOCKERT S5 SYSTEM, STOCKERT GAS BLENDER | Sorin Group Deutschland GmbH | 2008-07-30 |
| K071318 | MODIFICATION TO: STOCKERT S5 SYSTEM | Sorin Group Deutschland GmbH | 2007-07-06 |
| K070213 | PERFORMER CBP SYSTEM | Rand S.R.L. | 2007-03-21 |
| K062396 | MODIFICATION TO STOCKERT S5 SYSTEM | Sorin Group Deutschland GmbH | 2006-09-28 |
| K060053 | STOCKERT S5 SYSTEM | Sorin Group Deutschland GmbH | 2006-06-02 |
| K052555 | MEDTRONIC PERFORMER TM CPB, MODEL R51, PCPB | Rand S.R.L. | 2006-03-15 |
| K022947 | ADVANCED PERFUSION SYSTEM 1 (100/120 VOLT),ADVANCED PERFUSION SYSTEM 1 (220/240 VOLT, ROLLER PUMPS (6, 4 INCH | Terumo Cardiovascular Systems Corp. | 2003-03-20 |
| K030141 | MODIFICATION TO CARDIOVENTION POWERBASE CONSOLE, MODEL PCB-100 | Cardiovention, Inc. | 2003-02-26 |
| K021694 | CARDIOVENTION POWERBASE CONSOLE, MODEL PBC-100 | Cardiovention, Inc. | 2003-01-08 |
| K020571 | STOCKERT CENTRIFUGAL PUMP CONSOLE | Stockert Instrumente GmbH | 2002-09-23 |
| K011088 | SIII ALARM AMPLIFIER | Stockert Instrumente GmbH | 2001-05-02 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 04033817904144 | Device | LivaNova Deutschland GmbH | 2026-01-22 |
| 04033817904137 | Device | LivaNova Deutschland GmbH | 2026-01-22 |
| 04037691682907 | CARDIOHELP System | Maquet Cardiopulmonary AG | 2018-10-26 |
| 04037691651873 | MAQUET CARDIOHELP | Maquet Cardiopulmonary AG | 2017-03-13 |
| 04037691641041 | MAQUET CARDIOHELP | Maquet Cardiopulmonary AG | 2017-03-13 |
| 04037691224510 | Maquet HL-20 System | Maquet Cardiopulmonary AG | 2017-03-13 |
| 04037691211190 | MAQUET HL-20 System | Maquet Cardiopulmonary AG | 2017-03-13 |
| 04037691024110 | MAQUET HL20 | Maquet Cardiopulmonary AG | 2017-01-12 |
| 04037691816432 | MAQUET CARDIOHELP | Maquet Cardiopulmonary AG | 2017-01-10 |
| 00886799000830 | Terumo® Advanced Perfusion System 1 | Terumo Cardiovascular Systems Corporation | 2016-09-23 |
| 00886799001721 | Sarns™ Modular Perfusion System 8000 | Terumo Cardiovascular Systems Corporation | 2016-09-23 |
| 00886799000878 | Terumo® Advanced Perfusion System 1 | Terumo Cardiovascular Systems Corporation | 2016-09-23 |
| 00886799000847 | Terumo® Advanced Perfusion System 1 | Terumo Cardiovascular Systems Corporation | 2016-09-23 |
| 00886799000779 | Terumo® Advanced Perfusion System 1 | Terumo Cardiovascular Systems Corporation | 2016-09-23 |
| 00886799000762 | Terumo® Advanced Perfusion System 1 | Terumo Cardiovascular Systems Corporation | 2016-09-23 |
| 00886799000748 | Terumo® Advanced Perfusion System 1 | Terumo Cardiovascular Systems Corporation | 2016-09-23 |
| 00886799000731 | Terumo® Advanced Perfusion System 1 | Terumo Cardiovascular Systems Corporation | 2016-09-23 |
| 00886799000724 | Terumo® Advanced Perfusion System 1 | Terumo Cardiovascular Systems Corporation | 2016-09-23 |
| 00886799000687 | Terumo® Advanced Perfusion System 1 | Terumo Cardiovascular Systems Corporation | 2016-09-23 |
| 00886799000649 | Terumo® Advanced Perfusion System 1 | Terumo Cardiovascular Systems Corporation | 2016-09-23 |
| 00886799000595 | Terumo® Advanced Perfusion System 1 | Terumo Cardiovascular Systems Corporation | 2016-09-23 |
| 00886799000342 | Sarns™ Modular Perfusion System 8000 | Terumo Cardiovascular Systems Corporation | 2016-09-23 |
| 00886799000236 | Sarns™ Modular Perfusion System 8000 | Terumo Cardiovascular Systems Corporation | 2016-09-23 |
| 00886799000229 | Sarns™ Modular Perfusion System 8000 | Terumo Cardiovascular Systems Corporation | 2016-09-23 |
| 00886799000212 | Sarns™ Modular Perfusion System 8000 | Terumo Cardiovascular Systems Corporation | 2016-09-23 |
| 08033178104708 | DATA MASTER | SORIN GROUP ITALIA SRL | 2016-03-21 |
| 08033178104715 | DATA MASTER | SORIN GROUP ITALIA SRL | 2016-03-21 |
| 04037691658247 | MAQUET CARDIOHELP | Maquet Cardiopulmonary AG | 2015-11-06 |
| 04037691658384 | MAQUET CARDIOHELP | Maquet Cardiopulmonary AG | 2015-11-06 |
| 10886799001704 | Terumo® Advanced Perfusion System 1 | Terumo Cardiovascular Systems Corporation | 2015-09-24 |