FMD Peripheral Guide Wires F-14 and F-18, FMD Guide Wire Extension F-14 EXT— 510(k) K212268

Name: FDA 510(k) clearance K212268
Creator: U.S. Food and Drug Administration
Published: 2022-05-27

Substantially Equivalent

FMD Co., Ltd.

FDA 510(k) clearance K212268 for FMD Peripheral Guide Wires F-14 and F-18, FMD Guide Wire Extension F-14 EXT, Substantially Equivalent on 2022-05-27. Applicant: FMD Co., Ltd.. Device class: 2.

Clearance details

Applicant: FMD Co., Ltd.
Product code: Code DQX
Device class: Class 2
Regulation: 21 CFR 870.1330
Advisory panel: Cardiovascular
Date received: 2021-07-20
Decision date: 2022-05-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Shibuya-Ku, JP

Download summary PDF View on FDA.gov ↗

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K260544 — FMD Peripheral Guide Wire F-14 Flex 6 +4 more2026-03-20

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Adverse events under product code DQX

product code DQX

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 →

Data sourced from openFDA. This site is unofficial and independent of the FDA.