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VenaCure EVLT NeverTouch Procedure Kit

AngioDynamics, Inc.

Country / Region:United States (US)Submission type:Special

Product code GEX· 21 CFR 878.4810

Company

AngioDynamics, Inc. logoAngioDynamics, Inc.
United States (US)

Product code

GEX
21 CFR 878.4810

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Device details

FDA 510(k) registration fields

K number
K162914
Device name
VenaCure EVLT NeverTouch Procedure Kit
Company
AngioDynamics, Inc.
Country / Region
United States(US)
Product code
GEX
Device class
Class 2
Regulation number
21 CFR 878.4810
Date received
2016-10-17
Decision date
2016-11-16
Submission type
Special
Technology type
Diode(AI inferred)
Clinical applications
Vascular treatment
Primary application
Vascular treatment
Classification source
AI classified

Predicate devices

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Cited as predicate

1

1 submission cite K162914 as a predicate