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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 K071253
Device Name AFFINITY PEDIATRIC ARTERIAL FILTER, MODEL S4014 AND WITH CARMEDA BIOACTIVE SURFACE, MODEL CB4014
Applicant
MEDTRONIC VASCULAR
7611 NORTHLAND DR.
MINNEAPOLIS,  MN  55428
Applicant Contact JESSICA SIXBERRY
Correspondent
MEDTRONIC VASCULAR
7611 NORTHLAND DR.
MINNEAPOLIS,  MN  55428
Correspondent Contact JESSICA SIXBERRY
Regulation Number870.4260
Classification Product Code
DTM  
Date Received05/04/2007
Decision Date 07/03/2007
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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