LIPISCAN IVUS IMAGING SYSTEM MODEL NIRS-MC7-70

Catheter, Intravascular, Plaque Morphology Evaluation

Infraredx, Inc.

The following data is part of a premarket notification filed by Infraredx, Inc. with the FDA for Lipiscan Ivus Imaging System Model Nirs-mc7-70.

Pre-market Notification Details

Device IDK093993
510k NumberK093993
Device Name:LIPISCAN IVUS IMAGING SYSTEM MODEL NIRS-MC7-70
ClassificationCatheter, Intravascular, Plaque Morphology Evaluation
Applicant Infraredx, Inc. 34 THIRD AVE Burlington,  MA  01803 -4414
ContactSteven J Chartier
CorrespondentSteven J Chartier
Infraredx, Inc. 34 THIRD AVE Burlington,  MA  01803 -4414
Product CodeOGZ  
CFR Regulation Number870.1200 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2009-12-24
Decision Date2010-06-30
Summary:summary

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