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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name catheter, cannula and tubing, vascular, cardiopulmonary bypass
510(k) Number K120543
Device Name TANDEMHEART FEMORAL ARTERIAL CANNULA SET
Applicant
CARDIACASSIST INC.
240 ALPHA DRIVE
PITTSBURGH,  PA  15238
Applicant Contact KATIE DILLON
Correspondent
CARDIACASSIST INC.
240 ALPHA DRIVE
PITTSBURGH,  PA  15238
Correspondent Contact KATIE DILLON
Regulation Number870.4210
Classification Product Code
DWF  
Date Received02/23/2012
Decision Date 05/30/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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