# K133114: Micropuncture Introducer Set

- Pathway: 510(k) (Traditional)
- Applicant: Cook Incorporated
- Decided: Jul 3, 2014 after 276 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 K011084 (2001). 13 ancestors in all.
4 later devices descend from it; 2 cite it directly.
0 of 18 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K101604: Vsi Micro-Introducer Sets (Regular, Stiffen), Models 7197V-7209V, 7240V-7256V, 7259V, 7230V, 7231V, 7260V, 7274V, Vascular Solutions, Inc. (2011) Summary page 4.
- K112631: Vsi Guidewire, Vascular Solutions, Inc. (2011) Summary page 4.

## Most influential descendants
- 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 (2017), 2 descendants of its own
- 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
- K172980: Micropuncture Pedal Access Set (2018), 0 descendants of its own

## Indications for use
The Micropuncture Introducer Set is intended for the placement of wire guides up to .038 inch diameter into the peripheral vascular system when a small 21 gage needle stick is desired.

Source page: https://510kreport.com/device/K133114
Methodology: https://510kreport.com/methodology