FDA 510(k) Application Details - K142014

Device Classification Name Catheter, Percutaneous

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510(K) Number K142014
Device Name Catheter, Percutaneous
Applicant MICROVENTION, INC.
1311 VALENCIA AVE
TUSTIN, CA 92780 US
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Contact Naomi Gong
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Regulation Number 870.1250

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Classification Product Code DQY
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Date Received 07/24/2014
Decision Date 10/10/2014
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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