Asahi PTCA Guide Wire Asahi SION Series— 510(k) K191464

Substantially Equivalent

Asahi Intecc Co., Ltd.

FDA 510(k) clearance K191464 for Asahi PTCA Guide Wire Asahi SION Series, Substantially Equivalent on 2019-11-21. Applicant: Asahi Intecc Co., Ltd..

Clearance details

Applicant: Asahi Intecc Co., Ltd.
Product code: Code DQX
Advisory panel: Cardiovascular
Date received: 2019-06-03
Decision date: 2019-11-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Seto, JP

Download summary PDF View on FDA.gov ↗

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.