Cardiacassist, Inc.
Medical device manufacturer in Pittsburgh, PA.
21510(k) clearances
0PMA approvals
0recalls
Device types
- DWF Catheter, Cannula And Tubing, Vascular… 9
- KFM Pump, Blood, Cardiopulmonary Bypass… 4
- QNR Blood Pump For Ecmo, Long-Term (> 6 Hours)… 3
- DQR Cannula, Catheter 1
- DWA Control, Pump Speed, Cardiopulmonary Bypass 1
- DTZ Oxygenator, Cardiopulmonary Bypass 1
- DRE Dilator, Vessel, For Percutaneous… 1
- PZS Dual Lumen Ecmo Cannula 1
510(k) clearances
| 510(k) | Device | Decision |
|---|---|---|
| K233736 | LifeSPARC SystemQNR · Traditional | 01/19/2024SE |
| K232480 | ProtekDuo Veno-Venous Cannula SetsPZS · Traditional | 10/06/2023SE |
| K232132 | LifeSPARC SystemKFM · Special | 08/03/2023SE |
| K211830 | LifeSPARC SystemQNR · Traditional | 11/15/2022SE |
| K202751 | TandemHeart Pump and Escort ControllerQNR · Traditional | 03/26/2021SE |
| K183623 | LifeSPARC Pump, LifeSPARC ControllerKFM · Traditional | 07/09/2019SE |
| K181150 | ProtekDuo Mini Veno-Venous Cannula SetDWF · Special | 05/25/2018SE |
| K162181 | Protek Duo Venous Dilator Set, Protek Solo Venous Dilator SetDRE · Traditional | 01/06/2017SE |
| K162214 | Protek Solo 24 Fr Venous Cannula SetDWF · Traditional | 11/30/2016SE |
| K160257 | PROTEK Duo 31 Fr. Veno-Venous Cannula SetDWF · Special | 03/04/2016SE |
| K153295 | TandemLung OxygenatorDTZ · Traditional | 02/26/2016SE |
| K140999 | Tandemheart Veno-Venous CannulaDWF · Traditional | 08/06/2014SE |
| K133293 | 15 Fr. Tandemheart Arterial CannulaDWF · Special | 02/12/2014SE |
| K133236 | Tandemheart Femoral Venous Cannula SetDWF · Traditional | 01/29/2014SE |
| K120543 | Tandemheart Femoral Arterial Cannula SetDWF · Traditional | 05/30/2012SE |
| K110493 | Tandemheart PumpKFM · Traditional | 09/20/2011SE |
| K082425 | Tandemheart Transseptal Cannula- Ef 72DWF · Special | 09/18/2008SE |
| K061369 | Tandem Heart Escort (T.H.E.) Controller, Model 5140-8500DWA · Special | 08/22/2006SE |
| K052570 | Tandemheart Transseptal Cannula Set-Ef, Model 5140-6221DWF · Traditional | 01/17/2006SE |
| K030398 | Cardiacassist Transseptal Cannula Set, Model 5132-6221DQR · Traditional | 05/23/2003SE |
| K991783 | AB-180 XC System, Model AB-180XCKFM · Traditional | 11/01/2000SE |