FDA 510(k) Application Details - K011464

Device Classification Name Catheter, Percutaneous

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510(K) Number K011464
Device Name Catheter, Percutaneous
Applicant VASCULAR INTERVENTION
26531 YNEZ RD.
TEMECULA, CA 92591-0339 US
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Contact JENNIFER PAE RIGGS
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Regulation Number 870.1250

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Classification Product Code DQY
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Date Received 05/14/2001
Decision Date 06/13/2001
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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