# K254006: Drivewire 35 Guidewire

- Pathway: 510(k) (Traditional)
- Applicant: Rapid Medical Ltd.
- Decided: Jul 17, 2026 after 214 days
- Product code: MOF (Guide, Wire, Catheter, Neurovasculature)
- 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: 6 generations back to K002212 (2000). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K233791: Drivewire 24 Guidewire, Rapid-Medical, Ltd. (2024) Summary page 5.

## Indications for use
The Drivewire 35 Guidewire is intended for general intravascular use, including the neuro and peripheral vasculature. The Drivewire 35 Guidewire is intended to facilitate the selective placement of diagnostic or therapeutic catheters. This device is not intended for use in the coronary arteries.

Source page: https://510kreport.com/device/K254006
Methodology: https://510kreport.com/methodology