FDA 510(k) Application Details - K171866

Device Classification Name Introducer, Catheter

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510(K) Number K171866
Device Name Introducer, Catheter
Applicant Medtronic Vascular, Inc.
3576 Unocal Place
Santa Rosa, CA 95403 US
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Contact Wee Wen Leow
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Regulation Number 870.1340

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Classification Product Code DYB
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Date Received 06/22/2017
Decision Date 12/20/2017
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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