# K221351: Mechanical Guidewire

- Pathway: 510(k) (Traditional)
- Applicant: Baylis Medical Company, Inc.
- Decided: Dec 19, 2022 after 223 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: 1 generation back to K061670 (2007). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K061670: Lunderquist Wire Guide; DC Wire Guide, William Cook Europe Aps (2007) Summary page 4.

## Indications for use
The mechanical guidewire is intended for complex diagnostic and interventional procedures where increased body, flexibility, and low surface friction of the wire guide are needed. The guidewire is intended for peripheral vasculature use only, not intended for coronary or neurovascular use.

Source page: https://510kreport.com/device/K221351
Methodology: https://510kreport.com/methodology