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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 K934292
Device Name WILLIAM HARVEY HF5000 MEMBRANE OXYGENATOR
Applicant
Minntech Corp.
14905 28th Ave. N.
Minneapolis,  MN  55447
Applicant Contact SUSAN TESMER
Correspondent
Minntech Corp.
14905 28th Ave. N.
Minneapolis,  MN  55447
Correspondent Contact SUSAN TESMER
Regulation Number870.4350
Classification Product Code
DTZ  
Subsequent Product Code
DTR  
Date Received09/02/1993
Decision Date 07/26/1994
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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