# K170775: Mini Stick ENVI Non-Vascular Introducer Kit

- Pathway: 510(k) (Traditional)
- Applicant: AngioDynamics, Inc.
- Decided: Jul 19, 2017 after 127 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: 1 generation back to K952828 (1995). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K952828: Medi-Tech Percutaneous Introducer System, Boston Scientific Corp (1995) Summary page 4.

## Indications for use
The Mini Stick ENVI Non-Vascular Introducer Kit is utilized to facilitate the introduction and placement of a 0.035 in (0.89 mm) or 0.038 in (0.97 mm) diameter guidewire for non-vascular procedures.

Source page: https://510kreport.com/device/K170775
Methodology: https://510kreport.com/methodology