# K172980: Micropuncture Pedal Access Set

- Pathway: 510(k) (Traditional)
- Applicant: Cook Incorporated
- Decided: May 3, 2018 after 218 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: 7 generations back to K011084 (2001). 14 ancestors in all.
No later device cites it as a predicate yet.
0 of 15 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K133114: Micropuncture Introducer Set, Cook Incorporated (2014) Summary page 4.

## Indications for use
This device is intended to introduce up to an 0.038" wire guide into the peripheral vasculature. It is also used to introduce diagnostic and/or interventional devices able to pass through the ID of the introducer.

Source page: https://510kreport.com/device/K172980
Methodology: https://510kreport.com/methodology