VOLCANO S5I INTRAVASCULAR ULTRACOUND 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 S5i Intravascular Ultracound Imaging And Pressure System.

Pre-market Notification Details

Device IDK113486
510k NumberK113486
Device Name:VOLCANO S5I INTRAVASCULAR ULTRACOUND 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  
CFR Regulation Number892.1560 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2011-11-23
Decision Date2012-01-27
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00845225012809 K113486 000
00845225012748 K113486 000
00845225012670 K113486 000
00845225012571 K113486 000
00845225012076 K113486 000
00845225010300 K113486 000
00845225010256 K113486 000
00845225010096 K113486 000

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