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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 K121265
Device Name AMPHIRION PLUS PTA CATHETER
Applicant
MEDTRONIC INC.
3576 UNOCAL PLACE
SANTA ROSA,  CA  95403 -1774
Applicant Contact NAINESH SUREJA
Correspondent
MEDTRONIC INC.
3576 UNOCAL PLACE
SANTA ROSA,  CA  95403 -1774
Correspondent Contact NAINESH SUREJA
Regulation Number870.1250
Classification Product Code
LIT  
Date Received04/26/2012
Decision Date 05/22/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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