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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Heat-Exchanger, Cardiopulmonary Bypass
510(k) Number K003724
Device Name CBMYOTHERM XP CARDIOPLEGIA DELIVERY SYSTEM WITH CARMEDA BIOACTIVE SURFACE, MODELS CB41 AND CB41-B
Applicant
Medtronic Vascular
7600 Northland Dr.
Minneapolis,  MN  55428
Applicant Contact MARIE HOLM
Correspondent
Medtronic Vascular
7600 Northland Dr.
Minneapolis,  MN  55428
Correspondent Contact MARIE HOLM
Regulation Number870.4240
Classification Product Code
DTR  
Date Received12/04/2000
Decision Date 12/21/2000
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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