# K101604: Vsi Micro-Introducer Sets (Regular, Stiffen), Models 7197V-7209V, 7240V-7256V, 7259V, 7230V, 7231V, 7260V, 7274V

- Pathway: 510(k) (Traditional)
- Applicant: Vascular Solutions, Inc.
- Decided: Jan 24, 2011 after 230 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: 3 generations back to K932323 (1993). 4 ancestors in all.
6 later devices descend from it; 2 cite it directly.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K990705: Medamicus Coaxial Introducer Kit, 10330-XXX, Boston Scientific Coaxial Dilator Set, Medamicus, Inc. (1999) Summary page 1.
- K071574: Stiffer Coaxial Micro-Introducer Kit, Enpath Medical, Inc. (2007) Summary page 1.

## Most influential descendants
- K133114: Micropuncture Introducer Set (2014), 4 descendants of its own
- 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
- K180913: VSI Micro-Introducer Kit (2018), 0 descendants of its own

## Indications for use
The VSI Micro-Introducer Set is used for percutaneous introduction of up to an 0.038 inch guidewire or catheter into the vascular system following a small gauge needle stick.

Source page: https://510kreport.com/device/K101604
Methodology: https://510kreport.com/methodology