FDA 510(k) Applications Submitted by CARDIAC ASSIST, INC.
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K160257 |
02/01/2016 |
PROTEK Duo 31 Fr. Veno-Venous Cannula Set |
CARDIAC ASSIST, INC. |
| K162214 |
08/08/2016 |
Protek Solo 24 Fr Venous Cannula Set |
CARDIAC ASSIST, INC. |
| K133236 |
10/21/2013 |
TANDEMHEART FEMORAL VENOUS CANNULA SET |
CARDIAC ASSIST, INC. |
| K153295 |
11/13/2015 |
TandemLung Oxygenator |
CARDIAC ASSIST, INC. |
| K991783 |
05/25/1999 |
AB-180 XC SYSTEM, MODEL AB-180XC |
CARDIAC ASSIST, INC. |
| K061369 |
05/17/2006 |
TANDEM HEART ESCORT (T.H.E.) CONTROLLER, MODEL 5140-8500 |
CARDIAC ASSIST, INC. |
| K082425 |
08/22/2008 |
TANDEMHEART TRANSSEPTAL CANNULA- EF 72 |
CARDIAC ASSIST, INC. |
| K030398 |
02/06/2003 |
CARDIACASSIST TRANSSEPTAL CANNULA SET, MODEL 5132-6221 |
CARDIAC ASSIST, INC. |
| K052570 |
09/19/2005 |
TANDEMHEART TRANSSEPTAL CANNULA SET-EF, MODEL 5140-6221 |
CARDIAC ASSIST, INC. |
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