# K200374: Columbus Guidewire

- Pathway: 510(k) (Traditional)
- Applicant: Rapid-Medical, Ltd.
- Decided: Dec 14, 2020 after 304 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: 5 generations back to K953533 (1995). 7 ancestors in all.
No later device cites it as a predicate yet.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K133725: Traxcess 14 Guidewire, MicroVention, Inc. (2014) Summary page 4.

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

Source page: https://510kreport.com/device/K200374
Methodology: https://510kreport.com/methodology