# K180913: VSI Micro-Introducer Kit

- Pathway: 510(k) (Traditional)
- Applicant: Vascular Solutions, Inc.
- Decided: May 9, 2018 after 30 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: 4 generations back to K932323 (1993). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 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.

## Indications for use
VSI Micro-Introducer Kits are intended for use in percutaneous introduction of up to a 0.018 inch or 0.038 inch guidewire or catheter into the vascular system following a small gauge needle stick.

Source page: https://510kreport.com/device/K180913
Methodology: https://510kreport.com/methodology