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FDA 510(k) Application Details - K092596
Device Classification Name
Catheter, Ultrasound, Intravascular
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510(K) Number
K092596
Device Name
Catheter, Ultrasound, Intravascular
Applicant
VOLCANO CORPORATION
2870 KILGORE RD.
RANCHO CORDOVA, CA 95670 US
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Contact
LORRY HUFFMAN
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Regulation Number
870.1200
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Classification Product Code
OBJ
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More FDA Info for this Product Code
Date Received
08/24/2009
Decision Date
12/10/2009
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
CV - Cardiovascular
Review Advisory Committee
RA - Radiology
Statement / Summary / Purged Status
Summary
Type
Abbreviated
Reviewed By Third Party
N
Expedited Review
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