# K141981: Asahi Fubuki 043 / Asahi Fubuki

- Pathway: 510(k) (Traditional)
- Applicant: Asahi Intecc Co., Ltd.
- Decided: Mar 9, 2015 after 231 days
- Product code: DQY (Catheter, Percutaneous)
- 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: 3 generations back to K003880 (2001). 6 ancestors in all.
2 later devices descend 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)
- K090335: HD Guide Catheter, Concentric Medical, Inc. (2009) Summary page 4.
- K962362: Cordis Envoy & Vista Brite Tip Guiding Catheters, Cordis Corp. (1996) Summary page 4.
- K980453: Schneider Guider Softip Guiding Catheters, Boston Scientific Scimed, Inc. (1998) Summary page 4.

## Most influential descendants
- K213589: FUBUKI XF Neurovascular Long Sheath (2022), 1 descendant of its own
- K251560: FUBUKI XF-R Neurovascular Long Sheath (2025), 0 descendants of its own

## Indications for use
The ASAHI FUBUKI 043 and ASAHI FUBUKI Guide Catheters are 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 catheter is also intended to be used for injection of contrast media. Do not use this catheter other than for use in the neurovasculature.

Source page: https://510kreport.com/device/K141981
Methodology: https://510kreport.com/methodology