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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Suction Control, Intracardiac, Cardiopulmonary Bypass
510(k) Number K920077
Device Name NIKKISO NK PUMP
Applicant
International Medical Products, Inc.
4503 Moorland Ave.
Minneapolis,  MN  55435
Applicant Contact JEFFREY SHIDEMAN
Correspondent
International Medical Products, Inc.
4503 Moorland Ave.
Minneapolis,  MN  55435
Correspondent Contact JEFFREY SHIDEMAN
Regulation Number870.4430
Classification Product Code
DWD  
Date Received01/08/1992
Decision Date 09/29/1993
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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