# K170695: VenaCure EVLT NeverTouch Direct Introducer Sheath

- Pathway: 510(k) (Traditional)
- Applicant: AngioDynamics, Inc.
- Decided: May 30, 2017 after 84 days
- Product code: DYB (Introducer, Catheter)
- Device class: 2
- Regulation: 21 CFR 870.1340
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K000313 (2000). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K043525: Catheter Introducer, Galt Medical Corp. (2005) Summary page 5.

## Indications for use
The VenaCure EVLT NeverTouch Introducer Sheath is indicated for use with VenaCure EVLT NeverTouch Direct Kit to introduce the laser fiber into the peripheral vasculature

Source page: https://510kreport.com/device/K170695
Methodology: https://510kreport.com/methodology