Inno-Hydrowire— 510(k) K172187

Substantially Equivalent

Suzhou Innomed Medical Device Co., Ltd.

FDA 510(k) clearance K172187 for Inno-Hydrowire, Substantially Equivalent on 2018-04-11. Applicant: Suzhou Innomed Medical Device Co., Ltd..

Clearance details

Applicant: Suzhou Innomed Medical Device Co., Ltd.
Product code: Code DQX
Advisory panel: Cardiovascular
Date received: 2017-07-20
Decision date: 2018-04-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Suzhou, CN

Download summary PDF View on FDA.gov ↗

Adverse events under product code DQX

product code DQX

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 →

Data sourced from openFDA. This site is unofficial and independent of the FDA.