FDA 510(k) Applications Submitted by CARDIACASSIST INC.

FDA 510(k) Number Submission Date Device Name Applicant
K140999 04/18/2014 TANDEMHEART VENO-VENOUS CANNULA CARDIACASSIST INC.
K162181 08/04/2016 Protek Duo Venous Dilator Set, Protek Solo Venous Dilator Set CARDIACASSIST INC.
K133293 10/25/2013 15 FR. TANDEMHEART ARTERIAL CANNULA CARDIACASSIST INC.
K120543 02/23/2012 TANDEMHEART FEMORAL ARTERIAL CANNULA SET CARDIACASSIST INC.
K110493 02/22/2011 TANDEMHEART PUMP CARDIACASSIST INC.


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