FDA 510(k) Application Details - K112917

Device Classification Name Catheter, Percutaneous

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510(K) Number K112917
Device Name Catheter, Percutaneous
Applicant MEDTRONIC, INC.
8200 CORAL SEA STREET
MS MVS11
MOUNDS VIEW, MN 55112 US
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Contact DEBORAH KIDDER
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Regulation Number 870.1250

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Classification Product Code DQY
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Date Received 10/03/2011
Decision Date 10/27/2011
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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