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| LifeSPARC System (K232132) | Cardiacassist, Inc. | 2023-08-03 |
| LifeSPARC System (K211830) | Cardiacassist, Inc. | 2022-11-15 |
| TandemHeart Pump and Escort Controller (K202751) | Cardiacassist, Inc. | 2021-03-26 |
| LifeSPARC Pump, LifeSPARC Controller (K183623) | Cardiacassist, Inc. | 2019-07-09 |
| ProtekDuo Mini Veno-Venous Cannula Set (K181150) | Cardiacassist, Inc. | 2018-05-25 |
| Protek Duo Venous Dilator Set, Protek Solo Venous Dilator Set (K162181) | Cardiacassist, Inc. | 2017-01-06 |
| Protek Solo 24 Fr Venous Cannula Set (K162214) | Cardiacassist, Inc. | 2016-11-30 |
| PROTEK Duo 31 Fr. Veno-Venous Cannula Set (K160257) | Cardiacassist, Inc. | 2016-03-04 |
| TandemLung Oxygenator (K153295) | Cardiacassist, Inc. | 2016-02-26 |
| TANDEMHEART VENO-VENOUS CANNULA (K140999) | Cardiacassist, Inc. | 2014-08-06 |
| 15 FR. TANDEMHEART ARTERIAL CANNULA (K133293) | Cardiacassist, Inc. | 2014-02-12 |
| TANDEMHEART FEMORAL VENOUS CANNULA SET (K133236) | Cardiacassist, Inc. | 2014-01-29 |
| TANDEMHEART FEMORAL ARTERIAL CANNULA SET (K120543) | Cardiacassist, Inc. | 2012-05-30 |
| TANDEMHEART PUMP (K110493) | Cardiacassist, Inc. | 2011-09-20 |
| TANDEMHEART TRANSSEPTAL CANNULA- EF 72 (K082425) | Cardiacassist, Inc. | 2008-09-18 |
| TANDEM HEART ESCORT (T.H.E.) CONTROLLER, MODEL 5140-8500 (K061369) | Cardiacassist, Inc. | 2006-08-22 |
| TANDEMHEART TRANSSEPTAL CANNULA SET-EF, MODEL 5140-6221 (K052570) | Cardiacassist, Inc. | 2006-01-17 |
| CARDIACASSIST TRANSSEPTAL CANNULA SET, MODEL 5132-6221 (K030398) | Cardiacassist, Inc. | 2003-05-23 |
| AB-180 XC SYSTEM, MODEL AB-180XC (K991783) | Cardiacassist, Inc. | 2000-11-01 |