FDA 510(k) Application Details - K132030

Device Classification Name Introducer, Catheter

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510(K) Number K132030
Device Name Introducer, Catheter
Applicant MEDTRONIC INC.
8200 CORAL SEA STREET
MS MVS11
MOUNDS VIEW, MN 55112 US
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Contact CHECHAMMA VARUGHESE
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Regulation Number 870.1340

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Classification Product Code DYB
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Date Received 07/01/2013
Decision Date 09/27/2013
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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