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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Pump, Blood, Cardiopulmonary Bypass, Roller Type
510(k) Number K874771
Device Name ANGIOMED INTRODUCING SETS
Applicant
Angiomed U.S., Inc.
4081 E. La Palma Ave.,
Suite E
Anaheim,  CA  92807
Applicant Contact MICHAEL MCCALLUM
Correspondent
Angiomed U.S., Inc.
4081 E. La Palma Ave.,
Suite E
Anaheim,  CA  92807
Correspondent Contact MICHAEL MCCALLUM
Regulation Number870.4370
Classification Product Code
DWB  
Date Received11/19/1987
Decision Date 01/12/1988
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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