K212268

Substantially Equivalent

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

Applicant: FMD Co., Ltd.
Product code: DQX
Advisory panel: Cardiovascular
Date received: 2021-07-20
Decision date: 2022-05-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Shibuya-Ku, JP

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.