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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 K052570
Device Name TANDEMHEART TRANSSEPTAL CANNULA SET-EF, MODEL 5140-6221
Original Applicant
CARDIAC ASSIST, INC.
240 alpha dr.
pittsburgh,  PA  15238
Original Contact tim krauskopf
Regulation Number870.4210
Classification Product Code
DWF  
Date Received09/19/2005
Decision Date 01/17/2006
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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