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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name catheter, percutaneous
510(k) Number K103386
Device Name MEDTRONIC VASCULAR - HUB MATERIAL MODIFICATION TO THE 5F AND 8F LAUNCHER(R) GUIDE CATHETERS
Applicant
MEDTRONIC INC.
35-37A CHERRY HILL DRIVE
DANVERS,  MA  01923 -5186
Applicant Contact ANU GAUR
Correspondent
MEDTRONIC INC.
35-37A CHERRY HILL DRIVE
DANVERS,  MA  01923 -5186
Correspondent Contact ANU GAUR
Regulation Number870.1250
Classification Product Code
DQY  
Date Received11/18/2010
Decision Date 02/11/2011
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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