# K242824: PTFE Guidewire

- Pathway: 510(k) (Special)
- Applicant: Lake Region Medical
- Decided: Dec 6, 2024 after 79 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 K935170 (1994). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K935170: Cardiovascular and Vascular Guidewire Modifications, Lake Region Mfg., Inc. (1994) Summary page 5.

## Most influential descendants
- 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) (2026), 0 descendants of its own

## Indications for use
To facilitate the placement of devices for diagnostic and interventional procedures. These guidewires are not intended for PTCA use.

Source page: https://510kreport.com/device/K242824
Methodology: https://510kreport.com/methodology