FDA 510(k) Applications for Medical Device Product Code "DTQ"
(Console, Heart-Lung Machine, Cardiopulmonary Bypass)
| FDA 510(k) Number | Applicant | Device Name | Decision Date |
| K964017 | AVECOR CARDIOVASCULAR, INC. | AFFINITY BLOOD PUMP SYSTEM | 08/05/1997 |
| K021694 | CARDIOVENTION, INC. | CARDIOVENTION POWERBASE CONSOLE, MODEL PBC-100 | 01/08/2003 |
| K030141 | CARDIOVENTION, INC. | MODIFICATION TO CARDIOVENTION POWERBASE CONSOLE, MODEL PCB-100 | 02/26/2003 |
| K202125 | Century HLM, LLC | Century Perfusion System | 03/07/2021 |
| K943803 | JANUS BIOMEDICAL, INC. | JOSTRA HL-20 INTEGRATED PERFUSION SYSTEM | 01/30/1996 |
| K090006 | LIFEBRIDGE MEDIZINTECHNIK AG | LIFEBRIDGE B2T, MODEL 7001 | 10/15/2009 |
| K221373 | LivaNova Deutschland GmbH | Essenz HLM | 03/09/2023 |
| K232291 | LivaNova Deutschland GmbH | Essenz HLM, Essenz ILBM | 08/24/2023 |
| K210130 | LivaNova Deutschland GmbH | Stockert S5 System | 04/05/2021 |
| K133598 | MAQUET CARDIOPULMONARY AG | CARDIOHELP SYSTEM | 05/21/2014 |
| K102726 | MAQUET CARDIOPULMONARY AG | CARDIOHELP SYSTEM | 04/04/2011 |
| K002116 | MEDICAL DEVICE CONSULTANTS, INC. | S3 CARDIOPLEGIA CONTROL MODULE VERSION 2.0 | 08/09/2000 |
| K052555 | RAND S.R.L. | MEDTRONIC PERFORMER TM CPB, MODEL R51, PCPB | 03/15/2006 |
| K070213 | RAND S.R.L. | PERFORMER CBP SYSTEM | 03/21/2007 |
| K091007 | SORIN GROUP DEUTSCHLAND GMBH | AIR PURGE CONTROL SYSTEM FOR S5 SYSTEM MODEL 23-45-05 | 07/02/2009 |
| K062396 | SORIN GROUP DEUTSCHLAND GMBH | MODIFICATION TO STOCKERT S5 SYSTEM | 09/28/2006 |
| K071318 | SORIN GROUP DEUTSCHLAND GMBH | MODIFICATION TO: STOCKERT S5 SYSTEM | 07/06/2007 |
| K092463 | SORIN GROUP DEUTSCHLAND GMBH | SORIN B-CARE5 FOR THE STOCKERT S5 SYSTEM | 11/05/2009 |
| K093882 | SORIN GROUP DEUTSCHLAND GMBH | SORIN C5 SYSTEM MODEL 58-00-00 | 01/15/2010 |
| K103762 | SORIN GROUP DEUTSCHLAND GMBH | SORIN C5 SYSTEM; 85/C5 MAST ROLLER PUMP SYSTEM 150(1X RP 150 AND CONTROL PANEL WITH CONNECTING CABLES); S5/C5 MAST ROLLE | 01/20/2011 |
| K060053 | SORIN GROUP DEUTSCHLAND GMBH | STOCKERT S5 SYSTEM | 06/02/2006 |
| K080832 | SORIN GROUP DEUTSCHLAND GMBH | STOCKERT S5 SYSTEM, STOCKERT GAS BLENDER | 07/30/2008 |
| K173834 | Spectrum Medical Ltd | Quantum Pump Console | 05/25/2018 |
| K190282 | Spectrum Medical Ltd | Quantum Smart Occluder LH (left-hand), Quantum Smart Occluder LH (right-hand) | 05/24/2019 |
| K011088 | STOCKERT INSTRUMENTE GMBH | SIII ALARM AMPLIFIER | 05/02/2001 |
| K020571 | STOCKERT INSTRUMENTE GMBH | STOCKERT CENTRIFUGAL PUMP CONSOLE | 09/23/2002 |
| K982014 | STOECKERT INSTRUMENTE | STOCKERT COMPACT SYSTEM | 09/04/1998 |
| K002118 | STOECKERT INSTRUMENTE | STOCKERT COMPACT SYSTEM VERSION 2.0 | 08/09/2000 |
| K950990 | STOECKERT INSTRUMENTE | STOCKERT S3 ROLLER PUMP MODULE STOCKERT S3 CONSOLE | 01/19/1996 |
| K131041 | TERUMO CARDIOVASCULAR SYSTEMS CORP. | ADVANCED PERFUSION SYSTEM 1 | 02/20/2014 |
| K022947 | TERUMO CARDIOVASCULAR SYSTEMS CORP. | ADVANCED PERFUSION SYSTEM 1 (100/120 VOLT),ADVANCED PERFUSION SYSTEM 1 (220/240 VOLT, ROLLER PUMPS (6, 4 INCH | 03/20/2003 |
| K151349 | Terumo Cardiovascular Systems Corporation | Advanced Perfusion System 1 | 08/27/2015 |
| K153376 | Terumo Cardiovascular Systems Corporation | Advanced Perfusion System 1 | 12/16/2015 |
| K163531 | TERUMO CARDIOVASCULAR SYSTEMS CORPORATION | Advanced Perfusion System 1 | 06/07/2017 |
| K172220 | Terumo Cardiovascular Systems Corporation | Advanced Perfusion System 1 | 08/17/2017 |
| K221895 | Terumo Cardiovascular Systems Corporation | Terumo Advanced Perfusion System 1 | 04/18/2023 |
Search | Companies | Product Codes | Device Names | Contacts | Applications | Decisions | Contact
