# K213589: FUBUKI XF Neurovascular Long Sheath

- Pathway: 510(k) (Traditional)
- Applicant: Asahi Intecc Co., Ltd.
- Decided: Mar 24, 2022 after 132 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: 4 generations back to K003880 (2001). 7 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K141981: Asahi Fubuki 043 / Asahi Fubuki, Asahi Intecc Co., Ltd. (2015) Summary page 4.
- (no number) Asahi Fubuki 043: named in the summary without a submission number

## Most influential descendants
- K251560: FUBUKI XF-R Neurovascular Long Sheath (2025), 0 descendants of its own

## Indications for use
This product 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. This product is also intended to be used for injection of contrast media. This product is intended for use only in the neurovasculature.

Source page: https://510kreport.com/device/K213589
Methodology: https://510kreport.com/methodology