FDA 510(k) Application Details - K073473

Device Classification Name Catheter, Ultrasound, Intravascular

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510(K) Number K073473
Device Name Catheter, Ultrasound, Intravascular
Applicant VOLCANO CORPORATION
2870 KILGORE RD.
RANCHO CORDOVA, CA 95670 US
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Contact ARLENE BLADES
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Regulation Number 870.1200

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Classification Product Code OBJ
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Date Received 12/11/2007
Decision Date 01/14/2008
Decision SESE - SUBST EQUIV
Classification Advisory Committee CV - Cardiovascular
Review Advisory Committee RA - Radiology
Statement / Summary / Purged Status Summary
Type Special
Reviewed By Third Party N
Expedited Review



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