# K212268: FMD Peripheral Guide Wires F-14 and F-18, FMD Guide Wire Extension F-14 EXT

- Pathway: 510(k) (Traditional)
- Applicant: FMD Co., Ltd.
- Decided: May 27, 2022 after 311 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: 11 generations back to K890505 (1989). 29 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 31 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K150445: ASAHI Peripheral Guide Wire Series (ASAHI Gladius, ASAHI Halberd, ASAHI Gaia PV), Asahi Intecc Co., Ltd. (2015) Summary page 4.

## Most influential descendants
- 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 (2026), 0 descendants of its own

## Indications for use
The indications for use of the FMD Peripheral Guide Wires F-14 and F-18: The FMD Peripheral Guide Wires are intended to facilitate the placement and exchange of diagnostic and therapeutic devices during intravascular procedures. This device is intended for peripheral vascular use only. The indications for use of the FMD Guide Wire Extension F-14 EXT: The FMD Guide Wire Extension accessory is intended for extension of the working length of an already introduced guide wire when exchanging over-the-wire interventional devices during an angioplasty procedure.

Source page: https://510kreport.com/device/K212268
Methodology: https://510kreport.com/methodology