EAGLE EYE PLATINUM DIGITAL IVUS CATHETER

Catheter, Ultrasound, Intravascular

VOLCANO CORPORATION

The following data is part of a premarket notification filed by Volcano Corporation with the FDA for Eagle Eye Platinum Digital Ivus Catheter.

Pre-market Notification Details

Device IDK092596
510k NumberK092596
Device Name:EAGLE EYE PLATINUM DIGITAL IVUS CATHETER
ClassificationCatheter, Ultrasound, Intravascular
Applicant VOLCANO CORPORATION 2870 KILGORE RD. Rancho Cordova,  CA  95670
ContactLorry Huffman
CorrespondentLorry Huffman
VOLCANO CORPORATION 2870 KILGORE RD. Rancho Cordova,  CA  95670
Product CodeOBJ  
CFR Regulation Number870.1200 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeAbbreviated
3rd Party ReviewedNo
Combination ProductNo
Date Received2009-08-24
Decision Date2009-12-10
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00845225001278 K092596 000

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