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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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