VenaCure EVLT NeverTouch Procedure Kit

Powered Laser Surgical Instrument

AngioDynamics, Inc.

The following data is part of a premarket notification filed by Angiodynamics, Inc. with the FDA for Venacure Evlt Nevertouch Procedure Kit.

Pre-market Notification Details

Device IDK162914
510k NumberK162914
Device Name:VenaCure EVLT NeverTouch Procedure Kit
ClassificationPowered Laser Surgical Instrument
Applicant AngioDynamics, Inc. 26 Forest Street Marlborough,  MA  01752
ContactRobin Fuller
CorrespondentRobin Fuller
AngioDynamics, Inc. 26 Forest Street Marlborough,  MA  01752
Product CodeGEX  
CFR Regulation Number878.4810 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2016-10-17
Decision Date2016-11-16

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