FDA 510(k) Application Details - K031583

Device Classification Name Introducer, Catheter

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510(K) Number K031583
Device Name Introducer, Catheter
Applicant INTEGRATED VASCULAR SYSTEMS, INC.
743 NORTH PASTORIA AVE.
SUNNYVALE, CA 94085 US
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Contact SUSAN TURNER
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Regulation Number 870.1340

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Classification Product Code DYB
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Date Received 05/21/2003
Decision Date 06/16/2003
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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