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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Valve, Pressure Relief, Cardiopulmonary Bypass
510(k) Number K941492
Device Name PRESSURE RELIEF VALVE
Applicant
Circulatory Technology, Inc.
21 Singworth St.
Oyster Bay,  NY  11771
Applicant Contact YEHUDA TAMARI
Correspondent
Circulatory Technology, Inc.
21 Singworth St.
Oyster Bay,  NY  11771
Correspondent Contact YEHUDA TAMARI
Regulation Number870.4400
Classification Product Code
MNJ  
Date Received03/28/1994
Decision Date 10/26/1994
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
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