# K240589: Micropuncture Introducer Sets; Micropuncture Pedal Access Sets

- Pathway: 510(k) (Special)
- Applicant: Cook Medical
- Decided: Mar 25, 2024 after 24 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: 8 generations back to K011084 (2001). 15 ancestors in all.
No later device cites it as a predicate yet.
0 of 16 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K171275: Micropuncture Introducer Set, Micropuncture Introducer Set with Push-Plus Design, Micropuncture Introducer Set with Silhouette Transitionless Design,  Micropuncture Introducer Set with Silhouette Transitionless Design and Push-Plus Design, Cook Incorporated (2017) Summary page 5.

## Indications for use
The Micropuncture® Introducer Set is intended for the placement of wire guides up to 0.038-inch diameter into the peripheral vascular system when a small 21 gage needle stick is desired. The Micropuncture® Pedal Access Set 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/K240589
Methodology: https://510kreport.com/methodology