Ebony PTA 0.035 Peripheral Dilatation Catheter

Catheter, Angioplasty, Peripheral, Transluminal

Natec Medical Ltd

The following data is part of a premarket notification filed by Natec Medical Ltd with the FDA for Ebony Pta 0.035 Peripheral Dilatation Catheter.

Pre-market Notification Details

Device IDK143036
510k NumberK143036
Device Name:Ebony PTA 0.035 Peripheral Dilatation Catheter
ClassificationCatheter, Angioplasty, Peripheral, Transluminal
Applicant Natec Medical Ltd Maeva Centre Building Ebene Business Park Reduit,  MU 72201
ContactXavier De Buchere
CorrespondentJudith Danielson
CardioMed Device Consultants, LLC 5523 Research Park Drive Suite 205 Baltimore,  MD  21228
Product CodeLIT  
CFR Regulation Number870.1250 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2014-10-22
Decision Date2015-03-30
Summary:summary

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