FDA 510(k) Application Details - K143316

Device Classification Name Wire, Guide, Catheter

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510(K) Number K143316
Device Name Wire, Guide, Catheter
Applicant Medtronic, Inc.
8200 Coral Sea Street NE
Mounds View, MN 55112 US
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Contact Mia Hunt
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Regulation Number 870.1330

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Classification Product Code DQX
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Date Received 11/19/2014
Decision Date 03/11/2015
Decision SESE - SUBST EQUIV
Classification Advisory Committee CV - Cardiovascular
Review Advisory Committee CV - Cardiovascular
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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