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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Oxygenator, Cardiopulmonary Bypass
510(k) Number K000430
Device Name AFFINITY NT HOLLOW FIBER OXYGENATOR WITH PLASMA RESISTANT FIBER WITH CARMEDA BIOACTIVE SURFACE, MODEL CB511
Applicant
MEDTRONIC VASCULAR
4633 EAST LA PALMA AVE.
ANAHEIM,  CA  92807
Applicant Contact DEBRA KRIDNER
Correspondent
MEDTRONIC VASCULAR
4633 EAST LA PALMA AVE.
ANAHEIM,  CA  92807
Correspondent Contact DEBRA KRIDNER
Regulation Number870.4350
Classification Product Code
DTZ  
Date Received02/09/2000
Decision Date 02/25/2000
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
Recalls CDRH Recalls
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