FDA 510(k) Application Details - K142065

Device Classification Name Catheter, Percutaneous

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510(K) Number K142065
Device Name Catheter, Percutaneous
Applicant VASCULAR SOLUTIONS, INC.
6464 Sycamore Court North
Minneapolis, MN 55369 US
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Contact ELLIE GILLESPIE
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Regulation Number 870.1250

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Classification Product Code DQY
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Date Received 07/30/2014
Decision Date 11/25/2014
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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