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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Filter, Blood, Cardiopulmonary Bypass, Arterial Line
510(k) Number K862591
Device Name INTERFACE ARTERIAL BLOOD FILTER, MODEL 42
Applicant
Medical, Inc.
9605 W. Jefferson Trl.
Inver Grove Heights,  MN  55077
Applicant Contact RENATE M JOHNSON
Correspondent
Medical, Inc.
9605 W. Jefferson Trl.
Inver Grove Heights,  MN  55077
Correspondent Contact RENATE M JOHNSON
Regulation Number870.4260
Classification Product Code
DTM  
Date Received07/07/1986
Decision Date 09/04/1986
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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