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FDA 510(k) Application Details - K042996
Device Classification Name
Wire, Guide, Catheter
More FDA Info for this Device
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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More FDA Info for this Product Code
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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