FMD Peripheral Guide Wire F-18 Flex 400 (CSU415400259)— 510(k) K240460

Name: FDA 510(k) clearance K240460
Creator: U.S. Food and Drug Administration
Published: 2024-06-13

Substantially Equivalent

FMD Co., Ltd.

FDA 510(k) clearance K240460 for FMD Peripheral Guide Wire F-18 Flex 400 (CSU415400259), Substantially Equivalent on 2024-06-13. 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: 2024-02-16
Decision date: 2024-06-13
Decision: Substantially Equivalent
Clearance type: Special
Location: Shibuya-Ku, JP

Download summary PDF View on FDA.gov ↗

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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.