VASSALLO GT 018 G12; VASSALLO GT 018 G30— 510(k) K232578

Substantially Equivalent

Filmec Co. , Ltd.

FDA 510(k) clearance K232578 for VASSALLO GT 018 G12; VASSALLO GT 018 G30, Substantially Equivalent on 2023-10-11. Applicant: Filmec Co. , Ltd..

Clearance details

Applicant: Filmec Co. , Ltd.
Product code: Code DQX
Advisory panel: Cardiovascular
Date received: 2023-08-25
Decision date: 2023-10-11
Decision: Substantially Equivalent
Clearance type: Special
Location: Hagoya-Shi, JP

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.