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

Clearance details

Applicant

Asahi Intecc Co., Ltd.

Product code

Code MOF

Device class

Class 2

Regulation

21 CFR 870.1330

Advisory panel

Cardiovascular

Date received

2016-03-08

Decision date

2016-04-07

Decision

Substantially Equivalent

Clearance type

Special

Location

Santa Ana, CA, US

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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 →