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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type
510(k) Number K110493
Device Name TANDEMHEART PUMP
Applicant
CARDIACASSIST INC.
240 ALPHA DRIVE
PITTSBURGH,  PA  15238
Applicant Contact ROBERT BOLLINGER
Correspondent
CARDIACASSIST INC.
240 ALPHA DRIVE
PITTSBURGH,  PA  15238
Correspondent Contact ROBERT BOLLINGER
Regulation Number870.4360
Classification Product Code
KFM  
Date Received02/22/2011
Decision Date 09/20/2011
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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