# K251560: FUBUKI XF-R Neurovascular Long Sheath

- Pathway: 510(k) (Special)
- Applicant: Asahi Intecc Co., Ltd.
- Decided: Jun 20, 2025 after 30 days
- Product code: QJP (Catheter, Percutaneous, Neurovasculature)
- Device class: 2
- Regulation: 21 CFR 870.1250
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K003880 (2001). 8 ancestors in all.
No later device cites it as a predicate yet.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K213589: FUBUKI XF Neurovascular Long Sheath, Asahi Intecc Co., Ltd. (2022) Summary page 5.

## Indications for use
The FUBUKI XF-R Neurovascular Long Sheath is intended to be used to guide interventional devices for neurovascular therapy to a lesion or a procedural site for a percutaneous intravascular procedure in the neurovasculature. The FUBUKI XF-R Neurovascular Long Sheath is also intended to be used for injection of contrast media. The FUBUKI XF-R Neurovascular Long Sheath is intended for use only in the neurovasculature.

Source page: https://510kreport.com/device/K251560
Methodology: https://510kreport.com/methodology