Class Class II
Vassallo GT 018 Hybrid (K223432)
Description
Vassallo GT 018 Hybrid by Filmecc Co., Ltd., an FDA 510(k) cleared cardiovascular device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK223432
Clearance Date2023-03-09
Clearance TypeTraditional
Product CodeDQX
Regulation Number870.1330
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K223432
A 510(k) clearance is granted by showing substantial equivalence to an earlier legally marketed device, called the predicate. This lineage is named in the 510(k) summary document and is not published by the FDA as a connected dataset. Vassallo GT 018 Hybrid (K223432) cites 3 predicate devices and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K213949 | VASSALLO GT 018 Floppy | Filmecc Co., Ltd. | 2022 |
| K203529 | VASSALLO GT Hybrid | Filmecc Co., Ltd. | 2021 |
| K203533 | VASSALLO GT | Filmecc Co., Ltd. | 2021 |
Trace the full predicate network for K223432
A link appears here only where the predicate could be read from a published 510(k) summary. Where no summary exists or a reference cannot be resolved to a K number, no link is drawn, so a gap means unknown rather than none.