# 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

- Pathway: 510(k) (Special)
- Applicant: Cook Incorporated
- Decided: Dec 20, 2017 after 233 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.
2 later devices descend from it; 2 cite it directly.
0 of 17 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.

## Most influential descendants
- K253526: NAMIC Dilator and Sheath (2026), 0 descendants of its own
- K240589: Micropuncture Introducer Sets; Micropuncture Pedal Access Sets (2024), 0 descendants of its own

## 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.

Source page: https://510kreport.com/device/K171275
Methodology: https://510kreport.com/methodology