FDA 510(k) Application Details - K041134

Device Classification Name Catheter, Ultrasound, Intravascular

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510(K) Number K041134
Device Name Catheter, Ultrasound, Intravascular
Applicant VOLCANO THERAPEUTICS, INC.
2870 KILGORE RD.
RANCHO CORDOVA, CA 95670 US
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Contact LORRY W HUFFMAN
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Regulation Number 870.1200

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Classification Product Code OBJ
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Date Received 04/30/2004
Decision Date 06/02/2004
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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