ASAHI PTCA Guide Wire ASAHI Gladius Mongo 14, ASAHI Gladius Mongo 14 ES— 510(k) K180784

Clearance details

Applicant

Asahi Intecc Co., Ltd.

Product code

Code DQX

Device class

Class 2

Regulation

21 CFR 870.1330

Advisory panel

Cardiovascular

Date received

2018-03-26

Decision date

2018-07-18

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Seto, JP

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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 →