All’InCath 035M PTA Balloon Dilatation Catheter

Catheter, Angioplasty, Peripheral, Transluminal

NexStep Medical

The following data is part of a premarket notification filed by Nexstep Medical with the FDA for All’incath 035m Pta Balloon Dilatation Catheter.

Pre-market Notification Details

Device IDK191275
510k NumberK191275
Device Name:All’InCath 035M PTA Balloon Dilatation Catheter
ClassificationCatheter, Angioplasty, Peripheral, Transluminal
Applicant NexStep Medical 7-9 Place Saint Bernard Dijon,  FR 21000
ContactAngela Mallery
CorrespondentAngela Mallery
NAMSA 400 Highway 169 South, Suite 500 Minneapolis,  MN  55426
Product CodeLIT  
CFR Regulation Number870.1250 [🔎]
DecisionSubstantially Equivalent (SESE)
Regulation Medical SpecialtyCardiovascular
510k Review PanelCardiovascular
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-05-13
Decision Date2020-01-15

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