FDA 510(k) Application Details - K042996

Device Classification Name Wire, Guide, Catheter

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510(K) Number K042996
Device Name Wire, Guide, Catheter
Applicant VOLCANO THERAPEUTICS, INC.
2870 KILGORE RD.
RANCHO CORDOVA, CA 95670 US
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Contact LORRY HUFFMAN
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Regulation Number 870.1330

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Classification Product Code DQX
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Date Received 11/01/2004
Decision Date 11/24/2004
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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