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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name adaptor, stopcock, manifold, fitting, cardiopulmonary bypass
510(k) Number K052459
Device Name 6248VAL ADJUSTABLE VALVE
Applicant
MEDTRONIC VASCULAR
7000 CENTRAL AVENUE NE
MS CW304
MINNEAPOLIS,  MN  55432 -3576
Applicant Contact MICHELLE NIVALA
Correspondent
MEDTRONIC VASCULAR
7000 CENTRAL AVENUE NE
MS CW304
MINNEAPOLIS,  MN  55432 -3576
Correspondent Contact MICHELLE NIVALA
Regulation Number870.4290
Classification Product Code
DTL  
Date Received09/07/2005
Decision Date 01/11/2006
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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