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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name catheter, angioplasty, peripheral, transluminal
510(k) Number K103464
Device Name PACIFIC XTREME PTCA BALLOON DILATATION CATHETER
Applicant
MEDTRONIC INC.
37A CHERRY HILL DRIVE
DANVERS,  MA  01923
Applicant Contact HEATHER MOROSE
Correspondent
MEDTRONIC INC.
37A CHERRY HILL DRIVE
DANVERS,  MA  01923
Correspondent Contact HEATHER MOROSE
Regulation Number870.1250
Classification Product Code
LIT  
Subsequent Product Code
DQY  
Date Received11/24/2010
Decision Date 12/22/2010
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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