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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
Applicant
CARDIAC ASSIST, INC.
240 ALPHA DR.
PITTSBURGH,  PA  15238
Applicant Contact TIM KRAUSKOPF
Correspondent
CARDIAC ASSIST, INC.
240 ALPHA DR.
PITTSBURGH,  PA  15238
Correspondent 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
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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