# K251385: InQwire Super Stiff Guide Wire (IQSS32180J3); InQwire Super Stiff Guide Wire (IQSS35F260S); InQwire Super Stiff Guide Wire (IQSS35F150S); InQwire Super Stiff Guide Wire (IQSS35F100S); InQwire Super Stiff Guide Wire (IQSS35F80S); InQwire Super Stiff Guide Wire (IQSS35F180S)

- Pathway: 510(k) (Traditional)
- Applicant: Merit Medical Ireland, Ltd.
- Decided: Jan 21, 2026 after 261 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: 2 generations back to K935170 (1994). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K242824: PTFE Guidewire, Lake Region Medical (2024) Summary page 5.

## Indications for use
The InQwire Super Stiff Guide Wire is intended to facilitate the placement of devices during diagnostic and interventional procedures. The InQwire Super Stiff Guide Wire is indicated for use in the peripheral vasculature and chambers of the heart, excluding the coronary arteries and cerebral vasculature.

Source page: https://510kreport.com/device/K251385
Methodology: https://510kreport.com/methodology