# K260544: FMD Peripheral Guide Wire F-14 Flex 6; FMD Peripheral Guide Wire F-14 Tapered 40; FMD Peripheral Guide Wire F-18 Flex SP; FMD Peripheral Guide Wire F-18 DP 25; FMD Peripheral Guide Wire F-18 Tapered 40

- Pathway: 510(k) (Special)
- Applicant: FMD Co., Ltd.
- Decided: Mar 20, 2026 after 30 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: 12 generations back to K890505 (1989). 30 ancestors in all.
No later device cites it as a predicate yet.
0 of 31 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K212268: FMD Peripheral Guide Wires F-14 and F-18, FMD Guide Wire Extension F-14 EXT, FMD Co., Ltd. (2022) Summary page 5.

## Indications for use
FMD Peripheral Guidewires are intended to facilitate the placement and exchange of diagnostic and therapeutic devices during intravascular procedures. This device is intended for peripheral use only.

Source page: https://510kreport.com/device/K260544
Methodology: https://510kreport.com/methodology