# K112631: Vsi Guidewire

- Pathway: 510(k) (Traditional)
- Applicant: Vascular Solutions, Inc.
- Decided: Oct 27, 2011 after 48 days
- Product code: DQX (Wire, Guide, Catheter)
- Device class: 2
- Regulation: 21 CFR 870.1330
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K011084 (2001). 7 ancestors in all.
7 later devices descend from it; 3 cite it directly.
0 of 15 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K043398: Modification to Vascupuncture Picc Guidewire, Neometrics, Inc. (2005) Summary page 1.

## Cited in the summary but kept off the family tree
- K012861: Vascupuncture Access Wire, Neometrics, Inc. (2002). Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree

## 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
- K223791: TalWire (2023), 0 descendants of its own

## Indications for use
The VSI Guidewire is indicated for percutaneous entry of peripheral vessels using the Seldinger Technique. The device is not indicated for use in the coronary or cerebral vasculature.

Source page: https://510kreport.com/device/K112631
Methodology: https://510kreport.com/methodology