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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 K880831
Device Name LARGE LUMEN Y ADAPTER W/ROTATING DEVICE
Applicant
Interventional Medical, Inc.
P.O. Box 2186 35a Cherry Hill
Drive
Danvers,  MA  01923
Applicant Contact DENIS T KOKERNAK
Correspondent
Interventional Medical, Inc.
P.O. Box 2186 35a Cherry Hill
Drive
Danvers,  MA  01923
Correspondent Contact DENIS T KOKERNAK
Regulation Number870.4290
Classification Product Code
DTL  
Date Received03/01/1988
Decision Date 05/10/1988
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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