FDA Product Code
FDA Product Code DTQ — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Cardiovascular
- 21 CFR Citation
- 870.4220
510(k) Clearances — 52 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K232291 | Essenz HLM, Essenz ILBM | Livanova Deutschland, GmbH | 2023-08-24 | Special | PDF ↗ |
| K221895 | Terumo Advanced Perfusion System 1 | Terumo Cardiovascular Systems Corporation | 2023-04-18 | Traditional | PDF ↗ |
| K221373 | Essenz HLM | Livanova Deutschland, GmbH | 2023-03-09 | Traditional | PDF ↗ |
| K210130 | Stockert S5 System | Livanova Deutschland, GmbH | 2021-04-05 | Special | PDF ↗ |
| K202125 | Century Perfusion System | Century Hlm, LLC | 2021-03-07 | Traditional | PDF ↗ |
| K190282 | Quantum Smart Occluder LH (left-hand), Quantum Smart Occluder LH (right-hand) | Spectrum Medical , Ltd. | 2019-05-24 | Traditional | PDF ↗ |
| K173834 | Quantum Pump Console | Spectrum Medical , Ltd. | 2018-05-25 | Traditional | PDF ↗ |
| K172220 | Advanced Perfusion System 1 | Terumo Cardiovascular Systems Corporation | 2017-08-17 | Special | PDF ↗ |
| K163531 | Advanced Perfusion System 1 | Terumo Cardiovascular Systems Corporation | 2017-06-07 | Traditional | PDF ↗ |
| K153376 | Advanced Perfusion System 1 | Terumo Cardiovascular Systems Corporation | 2015-12-16 | Special | PDF ↗ |
| K151349 | Advanced Perfusion System 1 | Terumo Cardiovascular Systems Corporation | 2015-08-27 | Traditional | PDF ↗ |
| K133598 | CARDIOHELP SYSTEM | Maquet Cardiopulmonary, AG | 2014-05-21 | Traditional | PDF ↗ |
| K131041 | ADVANCED PERFUSION SYSTEM 1 | Terumo Cardiovascular Systems Corp. | 2014-02-20 | Traditional | PDF ↗ |
| K102726 | CARDIOHELP SYSTEM | Maquet Cardiopulmonary, AG | 2011-04-04 | Traditional | PDF ↗ |
| 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 | Special | PDF ↗ |
| K093882 | SORIN C5 SYSTEM MODEL 58-00-00 | Sorin Group Deutschland GmbH | 2010-01-15 | Special | PDF ↗ |
| K092463 | SORIN B-CARE5 FOR THE STOCKERT S5 SYSTEM | Sorin Group Deutschland GmbH | 2009-11-05 | Traditional | PDF ↗ |
| K090006 | LIFEBRIDGE B2T, MODEL 7001 | Lifebridge Medizintechnik AG | 2009-10-15 | Traditional | PDF ↗ |
| K091007 | AIR PURGE CONTROL SYSTEM FOR S5 SYSTEM MODEL 23-45-05 | Sorin Group Deutschland GmbH | 2009-07-02 | Special | PDF ↗ |
| K080832 | STOCKERT S5 SYSTEM, STOCKERT GAS BLENDER | Sorin Group Deutschland GmbH | 2008-07-30 | Special | PDF ↗ |
| K071318 | MODIFICATION TO: STOCKERT S5 SYSTEM | Sorin Group Deutschland GmbH | 2007-07-06 | Special | PDF ↗ |
| K070213 | PERFORMER CBP SYSTEM | Rand S.R.L. | 2007-03-21 | Traditional | PDF ↗ |
| K062396 | MODIFICATION TO STOCKERT S5 SYSTEM | Sorin Group Deutschland GmbH | 2006-09-28 | Special | PDF ↗ |
| K060053 | STOCKERT S5 SYSTEM | Sorin Group Deutschland GmbH | 2006-06-02 | Special | PDF ↗ |
| K052555 | MEDTRONIC PERFORMER TM CPB, MODEL R51, PCPB | Rand S.R.L. | 2006-03-15 | Traditional | PDF ↗ |
| 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 | Traditional | PDF ↗ |
| K030141 | MODIFICATION TO CARDIOVENTION POWERBASE CONSOLE, MODEL PCB-100 | Cardiovention, Inc. | 2003-02-26 | Special | PDF ↗ |
| K021694 | CARDIOVENTION POWERBASE CONSOLE, MODEL PBC-100 | Cardiovention, Inc. | 2003-01-08 | Traditional | PDF ↗ |
| K020571 | STOCKERT CENTRIFUGAL PUMP CONSOLE | Stockert Instrumente GmbH | 2002-09-23 | Traditional | PDF ↗ |
| K011088 | SIII ALARM AMPLIFIER | Stockert Instrumente GmbH | 2001-05-02 | Special | PDF ↗ |
| K002116 | S3 CARDIOPLEGIA CONTROL MODULE VERSION 2.0 | Medical Device Consultants, Inc. | 2000-08-09 | Special | PDF ↗ |
| K002118 | STOCKERT COMPACT SYSTEM VERSION 2.0 | Stoeckert Instrumente | 2000-08-09 | Special | PDF ↗ |
| K982014 | STOCKERT COMPACT SYSTEM | Stoeckert Instrumente | 1998-09-04 | Special | PDF ↗ |
| K964017 | AFFINITY BLOOD PUMP SYSTEM | Avecor Cardiovascular, Inc. | 1997-08-05 | Traditional | PDF ↗ |
| K943803 | JOSTRA HL-20 INTEGRATED PERFUSION SYSTEM | Janus Biomedical, Inc. | 1996-01-30 | Traditional | PDF ↗ |
| K950990 | STOCKERT S3 ROLLER PUMP MODULE STOCKERT S3 CONSOLE | Stoeckert Instrumente | 1996-01-19 | Traditional | PDF ↗ |
| K942582 | SORIN BLOOD CARDIOPLEGIA CONSOLE | Sorin Biomedical, Inc. | 1995-01-27 | Traditional | PDF ↗ |
| K915183 | SARNS 8000 MODULAR PERFUSION SYSTEM | 3M Health Care, Sarns | 1992-07-08 | Traditional | PDF ↗ |
| K871131 | SARNS 9000 HEART-LUNG CONSOLE | 3M Health Care, Sarns | 1987-05-21 | Traditional | PDF ↗ |
| K870976 | ONGUARD 1000, CATALOG #043611-000 & 043611-001 | Cobe Laboratories, Inc. | 1987-05-06 | Traditional | PDF ↗ |
| K863960 | STOCKERT-SHILEY CAPS BATTERY MODULE | Shiley, Inc. | 1986-12-11 | Traditional | PDF ↗ |
| K863541 | STOCKERT-SHILEY CAPS HLM INTERFACE | Shiley, Inc. | 1986-11-18 | Traditional | PDF ↗ |
| K862973 | STOCKERT-SHILEY CAPS TIMER MODULE | Shiley, Inc. | 1986-10-01 | Traditional | PDF ↗ |
| K861388 | SARNS PORTABLE POWER MODULE | 3M Health Care, Sarns | 1986-06-23 | Traditional | PDF ↗ |
| K851614 | CENTRIMED SYSTEM 1 W/24 VOLT BATTERY POWER SUPPLY | Centrimed Corp. | 1985-06-19 | Traditional | PDF ↗ |
| K851615 | CENTRIMED SYSTEM 1 W/MANUAL PUMP DRIVE | Centrimed Corp. | 1985-06-19 | Traditional | PDF ↗ |
| K842138 | COBE EMERGENCY POWER SOURCE 43610-000 | Cobe Laboratories, Inc. | 1984-08-03 | Traditional | PDF ↗ |
| K822068 | GAMBRO PUMP CONSOLE CSL | Gambro, Inc. | 1982-08-24 | Traditional | PDF ↗ |
| K813034 | POLYSTAN HEART LUNG MACHINE SYS | Advocacy International, Ltd. | 1981-11-27 | Traditional | PDF ↗ |
| K801097 | SARNS 7000 MONITOR MODULE | 3M Health Care, Sarns | 1980-05-20 | Traditional | PDF ↗ |
| K772001 | SARNES HELP | 3M Health Care, Sarns | 1977-11-02 | Traditional | PDF ↗ |
| K770002 | CONSOLE, MOBILE FOR 3 PUMPS W/MASTS | Cobe Laboratories, Inc. | 1977-03-07 | Traditional | PDF ↗ |
Product code DTQ · Class II · Cardiovascular. Data: openFDA.