ASAHI CHIKAI Neurovascular Guide Wire (Round Curve)— 510(k) K160659

Substantially Equivalent

Asahi Intecc Co., Ltd.

FDA 510(k) clearance K160659 for ASAHI CHIKAI Neurovascular Guide Wire (Round Curve), Substantially Equivalent on 2016-04-07. Applicant: Asahi Intecc Co., Ltd..

Clearance details

Applicant: Asahi Intecc Co., Ltd.
Product code: Code MOF
Advisory panel: Cardiovascular
Date received: 2016-03-08
Decision date: 2016-04-07
Decision: Substantially Equivalent
Clearance type: Special
Location: Santa Ana, CA, US

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.