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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Injector And Syringe, Angiographic
510(k) Number K902475
Device Name CARDIO-PAK ANGIOGRAPHY CUSTOM PACKS
Applicant
Cardio-Pak
1602 4th Ave.North
Billings,  MT  59101
Applicant Contact JEROME E DERNBACH
Correspondent
Cardio-Pak
1602 4th Ave.North
Billings,  MT  59101
Correspondent Contact JEROME E DERNBACH
Regulation Number870.1650
Classification Product Code
DXT  
Date Received06/04/1990
Decision Date 12/03/1990
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
Recalls CDRH Recalls
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