FMD Peripheral Guide Wire F-14 Flex 6 +4 more— 510(k) K260544

Clearance details

Device name as filed

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

Applicant

FMD Co., Ltd.

Product code

Code DQX

Device class

Class 2

Regulation

21 CFR 870.1330

Advisory panel

Cardiovascular

Date received

2026-02-18

Decision date

2026-03-20

Decision

Substantially Equivalent

Clearance type

Special

Location

Shibuya-Ku, JP

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• K254137 — InQwire Amplatz Guide Wire2026-05-22
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• K240460 — FMD Peripheral Guide Wire F-18 Flex 400 (CSU415400259)2024-06-13
• K212268 — FMD Peripheral Guide Wires F-14 and F-18, FMD Guide Wire Extension F-14 EXT2022-05-27

Death

298

Injury

4,385

Malfunction

7,203

Other

5

Total

11,891

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →