VASSALLO GT 018 Floppy— 510(k) K213949

Name: FDA 510(k) clearance K213949
Creator: U.S. Food and Drug Administration
Published: 2022-06-30

Substantially Equivalent

Filmecc Co., Ltd.

FDA 510(k) clearance K213949 for VASSALLO GT 018 Floppy, Substantially Equivalent on 2022-06-30. Applicant: Filmecc Co., Ltd.. Device class: 2.

Clearance details

Applicant: Filmecc Co., Ltd.
Product code: Code DQX
Device class: Class 2
Regulation: 21 CFR 870.1330
Advisory panel: Cardiovascular
Date received: 2021-12-17
Decision date: 2022-06-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hagoya-Shi, JP

Download summary PDF View on FDA.gov ↗

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More clearances from Filmecc Co., Ltd.

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K223432 — Vassallo GT 018 Hybrid2023-03-09
K222631 — VASSALLO GT EXT2022-10-26
K203529 — VASSALLO GT Hybrid2021-05-04
K203533 — VASSALLO GT2021-04-21

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.