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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 K910845
Device Name ITC ROTATING HEMOSTATIC VALVE CAT. NO. MX 1012
Applicant
Interventional Therapeutics Corp.
385 Oyster Pt. Blvd., Suite #6
South San Francisco,  CA  94080
Applicant Contact LUANNE TERMEER
Correspondent
Interventional Therapeutics Corp.
385 Oyster Pt. Blvd., Suite #6
South San Francisco,  CA  94080
Correspondent Contact LUANNE TERMEER
Regulation Number870.4290
Classification Product Code
DTL  
Date Received02/27/1991
Decision Date 05/21/1991
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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