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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 K162214
Device Name Protek Solo 24 Fr Venous Cannula Set
Applicant
CARDIAC ASSIST, INC.
240 ALPHA DR.
PITTSBURGH,  PA  15238
Applicant Contact GREG JOHNSON
Correspondent
CARDIAC ASSIST, INC.
240 ALPHA DR.
PITTSBURGH,  PA  15238
Correspondent Contact GREG JOHNSON
Regulation Number870.4210
Classification Product Code
DWF  
Date Received08/08/2016
Decision Date 11/30/2016
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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