ASAHI Neurovascular Guide Wire: ASAHI CHIKAI black 14 soft tip— 510(k) K161912

Substantially Equivalent

Asahi Intecc Co., Ltd.

FDA 510(k) clearance K161912 for ASAHI Neurovascular Guide Wire: ASAHI CHIKAI black 14 soft tip, Substantially Equivalent on 2016-10-14. Applicant: Asahi Intecc Co., Ltd..

Clearance details

Applicant: Asahi Intecc Co., Ltd.
Product code: Code MOF
Advisory panel: Cardiovascular
Date received: 2016-07-12
Decision date: 2016-10-14
Decision: Substantially Equivalent
Clearance type: Special
Location: Hagoya-Shi, JP

Download summary PDF View on FDA.gov ↗

Adverse events under product code MOF

product code MOF

Death: 6
Injury: 137
Total: 143

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.