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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 K951089
Device Name SCIMED GATEWAY PLUS
Applicant
Scimed Life Systems, Inc.
One Scimed Pl.
Maple Grove,  MN  55311
Applicant Contact DIANE M LOWE
Correspondent
Scimed Life Systems, Inc.
One Scimed Pl.
Maple Grove,  MN  55311
Correspondent Contact DIANE M LOWE
Regulation Number870.4290
Classification Product Code
DTL  
Date Received03/09/1995
Decision Date 05/31/1995
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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