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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name wire, guide, catheter
510(k) Number K091582
Device Name GTX GUIDEWIRE, MODELS TBD-GTX 1, 3,6,9,12, 15
Applicant
MEDTRONIC VASCULAR
37A CHERRY HILL DRIVE
DANVERS,  MA  01923
Applicant Contact COLLEEN MULLINS
Correspondent
MEDTRONIC VASCULAR
37A CHERRY HILL DRIVE
DANVERS,  MA  01923
Correspondent Contact COLLEEN MULLINS
Regulation Number870.1330
Classification Product Code
DQX  
Date Received06/02/2009
Decision Date 12/04/2009
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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