REVOLUTION 45MHZ IVUS IMAGING CATHETER

Catheter, Ultrasound, Intravascular

VOLCANO CORPORATION

The following data is part of a premarket notification filed by Volcano Corporation with the FDA for Revolution 45mhz Ivus Imaging Catheter.

Pre-market Notification Details

Device IDK080891
510k NumberK080891
Device Name:REVOLUTION 45MHZ IVUS IMAGING CATHETER
ClassificationCatheter, Ultrasound, Intravascular
Applicant VOLCANO CORPORATION 2870 KILGORE RD. Rancho Cordova,  CA  95670
ContactJennifer Motto
CorrespondentJennifer Motto
VOLCANO CORPORATION 2870 KILGORE RD. Rancho Cordova,  CA  95670
Product CodeOBJ  
CFR Regulation Number870.1200 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2008-03-31
Decision Date2008-05-12
Summary:summary

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