FDA 510(k) Application Details - K121265

Device Classification Name Catheter, Angioplasty, Peripheral, Transluminal

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510(K) Number K121265
Device Name Catheter, Angioplasty, Peripheral, Transluminal
Applicant MEDTRONIC INC.
3576 UNOCAL PLACE
SANTA ROSA, CA 95403-1774 US
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Contact NAINESH SUREJA
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Regulation Number 870.1250

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Classification Product Code LIT
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Date Received 04/26/2012
Decision Date 05/22/2012
Decision SESE - SUBST EQUIV
Classification Advisory Committee CV - Cardiovascular
Review Advisory Committee CV - Cardiovascular
Statement / Summary / Purged Status Summary
Type Special
Reviewed By Third Party N
Expedited Review



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