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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 K100470
Device Name GTX 12 GIDEWIRE
Applicant
MEDTRONIC INC.
37A CHERRY HILL DRIVE
DANVERS,  MA  01923
Applicant Contact COLLEEN MULLINS
Correspondent
MEDTRONIC INC.
37A CHERRY HILL DRIVE
DANVERS,  MA  01923
Correspondent Contact COLLEEN MULLINS
Regulation Number870.1330
Classification Product Code
DQX  
Date Received02/18/2010
Decision Date 04/21/2010
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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