ASAHI Neurovascular Guide Wire CHIKAI X 014 soft— 510(k) K191714

Substantially Equivalent

Asahi Intecc Co., Ltd.

FDA 510(k) clearance K191714 for ASAHI Neurovascular Guide Wire CHIKAI X 014 soft, Substantially Equivalent on 2019-07-26. Applicant: Asahi Intecc Co., Ltd..

Clearance details

Applicant: Asahi Intecc Co., Ltd.
Product code: Code MOF
Advisory panel: Cardiovascular
Date received: 2019-06-26
Decision date: 2019-07-26
Decision: Substantially Equivalent
Clearance type: Special
Location: Seto, 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.