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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass
510(k) Number K854261
Device Name ADVANCED CARDIOVASCULAR SYSTEMS HEMOSTATIC VALVES
Applicant
Advanced Cardiovascular Systems, Inc.
1395 Charleston Rd.
Mountain View,  CA  94043
Applicant Contact JANE E BEGGS
Correspondent
Advanced Cardiovascular Systems, Inc.
1395 Charleston Rd.
Mountain View,  CA  94043
Correspondent Contact JANE E BEGGS
Regulation Number870.4290
Classification Product Code
DTL  
Date Received10/23/1985
Decision Date 12/04/1985
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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