# K151234: R350 guidewire

- Pathway: 510(k) (Traditional)
- Applicant: Vascular Solutions, Inc.
- Decided: Nov 18, 2015 after 194 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: 13 generations back to K890505 (1989). 25 ancestors in all.
5 later devices descend from it; 1 cites it directly.
0 of 31 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K021990: Galt Medical Guidewire, Galt Medical Corp. (2002) Summary page 4.
- K141339: Asahi RG3 Guidewire/Asahi RG3 Soft Guidewire, Asahi Intecc Co., Ltd. (2014) Summary page 4.

## Most influential descendants
- K161702: Endura guidewire (2016), 4 descendants of its own
- K163444: Spectre guidewire (2017), 3 descendants of its own
- K173532: Raider Guidewire (2017), 1 descendant of its own
- K181647: Bandit guidewire (2018), 0 descendants of its own
- K180128: Warrior 14 guidewire (2018), 0 descendants of its own

## Indications for use
The R350 guidewire is indicated for use in percutaneous procedures to introduce and position catheters and other interventional devices within the coronary and/or peripheral vasculature

Source page: https://510kreport.com/device/K151234
Methodology: https://510kreport.com/methodology