Company ยท US
Cardiacassist, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 2000 to 2024. Name variants (Inc, Corp, punctuation) are merged.
21510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| DWF | Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass | 9 |
| KFM | Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type | 4 |
| QNR | Blood Pump For Ecmo, Long-Term (> 6 Hours) Use | 3 |
| DQR | Cannula, Catheter | 1 |
| DRE | Dilator, Vessel, For Percutaneous Catheterization | 1 |
| DTZ | Oxygenator, Cardiopulmonary Bypass | 1 |
| DWA | Control, Pump Speed, Cardiopulmonary Bypass | 1 |
| PZS | Dual Lumen Ecmo Cannula | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jan 19, 2024 | K233736 | LifeSPARC System Cardiacassist, Inc. | QNR |
| Oct 6, 2023 | K232480 | ProtekDuo Veno-Venous Cannula Sets Cardiacassist, Inc. | PZS |
| Aug 3, 2023 | K232132 | LifeSPARC System Cardiacassist, Inc. | KFM |
| Nov 15, 2022 | K211830 | LifeSPARC System Cardiacassist, Inc. | QNR |
| Mar 26, 2021 | K202751 | TandemHeart Pump and Escort Controller Cardiacassist, Inc. | QNR |
| Jul 9, 2019 | K183623 | LifeSPARC Pump, LifeSPARC Controller Cardiacassist, Inc. | KFM |
| May 25, 2018 | K181150 | ProtekDuo Mini Veno-Venous Cannula Set Cardiacassist, Inc. | DWF |
| Jan 6, 2017 | K162181 | Protek Duo Venous Dilator Set, Protek Solo Venous Dilator Set Cardiacassist, Inc. | DRE |
| Nov 30, 2016 | K162214 | Protek Solo 24 Fr Venous Cannula Set Cardiacassist, Inc. | DWF |
| Mar 4, 2016 | K160257 | PROTEK Duo 31 Fr. Veno-Venous Cannula Set Cardiacassist, Inc. | DWF |
| Feb 26, 2016 | K153295 | TandemLung Oxygenator Cardiacassist, Inc. | DTZ |
| Aug 6, 2014 | K140999 | TANDEMHEART VENO-VENOUS CANNULA Cardiacassist, Inc. | DWF |
| Feb 12, 2014 | K133293 | 15 FR. TANDEMHEART ARTERIAL CANNULA Cardiacassist, Inc. | DWF |
| Jan 29, 2014 | K133236 | TANDEMHEART FEMORAL VENOUS CANNULA SET Cardiacassist, Inc. | DWF |
| May 30, 2012 | K120543 | TANDEMHEART FEMORAL ARTERIAL CANNULA SET Cardiacassist, Inc. | DWF |
| Sep 20, 2011 | K110493 | TANDEMHEART PUMP Cardiacassist, Inc. | KFM |
| Sep 18, 2008 | K082425 | TANDEMHEART TRANSSEPTAL CANNULA- EF 72 Cardiacassist, Inc. | DWF |
| Aug 22, 2006 | K061369 | TANDEM HEART ESCORT (T.H.E.) CONTROLLER, MODEL 5140-8500 Cardiacassist, Inc. | DWA |
| Jan 17, 2006 | K052570 | TANDEMHEART TRANSSEPTAL CANNULA SET-EF, MODEL 5140-6221 Cardiacassist, Inc. | DWF |
| May 23, 2003 | K030398 | CARDIACASSIST TRANSSEPTAL CANNULA SET, MODEL 5132-6221 Cardiacassist, Inc. | DQR |
| Nov 1, 2000 | K991783 | AB-180 XC SYSTEM, MODEL AB-180XC Cardiacassist, Inc. | KFM |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||