FLUORO CATHETER

System, X-ray, Fluoroscopic, Image-intensified

CMT MEDICAL TECHNOLOGIES, LTD.

The following data is part of a premarket notification filed by Cmt Medical Technologies, Ltd. with the FDA for Fluoro Catheter.

Pre-market Notification Details

Device IDK953950
510k NumberK953950
Device Name:FLUORO CATHETER
ClassificationSystem, X-ray, Fluoroscopic, Image-intensified
Applicant CMT MEDICAL TECHNOLOGIES, LTD. MATAM HIGH TECHNOLOGY CENTER Haifa,  IL 31905
ContactImre Farkash
CorrespondentImre Farkash
CMT MEDICAL TECHNOLOGIES, LTD. MATAM HIGH TECHNOLOGY CENTER Haifa,  IL 31905
Product CodeJAA  
CFR Regulation Number892.1650 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1995-08-22
Decision Date1995-09-18

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