# K253667: Accoat Guide Wire

- Pathway: 510(k) (Traditional)
- Applicant: Sp Medical A/S
- Decided: Jul 14, 2026 after 235 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: 3 generations back to K002289 (2000). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K171764: Fixed Core Wire Guides, Cook Incorporated (2018) Summary page 5.

## Indications for use
The Accoat Guide Wire is intended to facilitate placement of devices during diagnostic and interventional procedures. It is not intended for use in the coronary vasculature or neurovasculature.

Source page: https://510kreport.com/device/K253667
Methodology: https://510kreport.com/methodology