# K170020: Peel-Away Introducer Set

- Pathway: 510(k) (Traditional)
- Applicant: Cook Incorporated
- Decided: Sep 28, 2017 after 268 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: 5 generations back to K000313 (2000). 13 ancestors in all.
1 later device descends from it; 1 cites it directly.
1 of 15 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K153533: Tearaway Introducer Sheath, MicroSlide Tearaway Introducer, Galt Medical Corp. (2016) Summary page 4.
- K093312: Kimberly-Clark Gastrointestinal Anchor Set with Saf-T-Pexy Fasteners, Enternal Access Dilation System, Kimberly-Clark Corp. (2009) Summary page 4.

## Most influential descendants
- K173685: Peel-Away Introducer Set (2017), 0 descendants of its own

## Indications for use
The Peel-Away Introducer Set is intended for the percutaneous introduction of balloon, electrode and closed or non-tapered end catheters into central and peripheral vasculature, and for non-vascular use.

Source page: https://510kreport.com/device/K170020
Methodology: https://510kreport.com/methodology