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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 K000379
Device Name MODOFICATION TO AFFFINITY 38 MICRO ARTERIAL BLOOD FILTER WITH CARMEDA BIOACTIVE SURFACE, MODELS CB351/CB352
Applicant
Medtronic Vascular
4633 E. Lapalma Ave.
Anaheim,  CA  92807
Applicant Contact MARIE HOLM
Correspondent
Medtronic Vascular
4633 E. Lapalma Ave.
Anaheim,  CA  92807
Correspondent Contact MARIE HOLM
Regulation Number870.4260
Classification Product Code
DTM  
Date Received02/07/2000
Decision Date 02/16/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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