# K042264: Guidewires

- Pathway: 510(k) (Traditional)
- Applicant: Rocket Medical Plc
- Decided: Nov 24, 2004 after 93 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
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names no predicate by number.

## Most influential descendants
- K061661: Sta Cath Attachable Infision Catheter, Model STA20 (2006), 0 descendants of its own

## Indications for use
The Guidewires are intended to fit inside a percutaneous catheter for the purpose of directing it through a blood vessel or other natural channel - excluding use in coronary arteries and in the neurovasculature.

Source page: https://510kreport.com/device/K042264
Methodology: https://510kreport.com/methodology