VOLCANO ANGIO-IVUS MAPPING (AIM) 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 Angio-ivus Mapping (aim) System.

Pre-market Notification Details

Device IDK060483
510k NumberK060483
Device Name:VOLCANO ANGIO-IVUS MAPPING (AIM) SYSTEM
ClassificationSystem, Imaging, Pulsed Echo, Ultrasonic
Applicant VOLCANO CORPORATION 2870 KILGORE RD. Rancho Cordova,  CA  95670
ContactMichelle J Badal
CorrespondentMichelle J Badal
VOLCANO CORPORATION 2870 KILGORE RD. Rancho Cordova,  CA  95670
Product CodeIYO  
CFR Regulation Number892.1560 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2006-02-24
Decision Date2006-06-23
Summary:summary

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