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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Oxygenator, Cardiopulmonary Bypass
510(k) Number K843956
Device Name SCIMED II MEMBRANE OXYGENATOR SYSTEM
Applicant
Scimed Life Systems, Inc.
13000 County Rd. 6
Minneapolis,  MN  55441
Applicant Contact MICHAEL T FRANKENBE
Correspondent
Scimed Life Systems, Inc.
13000 County Rd. 6
Minneapolis,  MN  55441
Correspondent Contact MICHAEL T FRANKENBE
Regulation Number870.4350
Classification Product Code
DTZ  
Date Received10/09/1984
Decision Date 01/08/1985
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
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