VOLCANO S5IINTRAVASCULAR IMAGING AND PRESSURE SYSTEM

System, Imaging, Pulsed Echo, Ultrasonic

VOLCANO CORPORATION

The following data is part of a premarket notification filed by Volcano Corporation with the FDA for Volcano S5iintravascular Imaging And Pressure System.

Pre-market Notification Details

Device IDK111706
510k NumberK111706
Device Name:VOLCANO S5IINTRAVASCULAR IMAGING AND PRESSURE SYSTEM
ClassificationSystem, Imaging, Pulsed Echo, Ultrasonic
Applicant VOLCANO CORPORATION 2870 KILGORE RD. Rancho Cordova,  CA  95670
ContactJwala Jawharkar
CorrespondentJwala Jawharkar
VOLCANO CORPORATION 2870 KILGORE RD. Rancho Cordova,  CA  95670
Product CodeIYO  
Subsequent Product CodeDSA
Subsequent Product CodeDSK
CFR Regulation Number892.1560 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2011-06-17
Decision Date2011-07-15
Summary:summary

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