# K173685: Peel-Away Introducer Set

- Pathway: 510(k) (Special)
- Applicant: Cook Incorporated
- Decided: Dec 20, 2017 after 19 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: 6 generations back to K000313 (2000). 14 ancestors in all.
No later device cites it as a predicate yet.
1 of 15 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K170020: Peel-Away Introducer Set, Cook Incorporated (2017) Summary page 4.

## 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 nonvascular use.

Source page: https://510kreport.com/device/K173685
Methodology: https://510kreport.com/methodology