Class Class II
FUBUKI XF-R Neurovascular Long Sheath (K251560)
Description
FUBUKI XF-R Neurovascular Long Sheath by Asahi Intecc Co., Ltd., an FDA 510(k) cleared cardiovascular device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK251560
Clearance Date2025-06-20
Clearance TypeSpecial
Product CodeQJP
Regulation Number870.1250
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K251560
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. FUBUKI XF-R Neurovascular Long Sheath (K251560) cites 1 predicate device and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K213589 | FUBUKI XF Neurovascular Long Sheath | Asahi Intecc Co., Ltd. | 2022 |
Trace the full predicate network for K251560
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.