# K251240: Branchor X Balloon Guide Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Asahi Intecc Co., Ltd.
- Decided: Jun 20, 2025 after 59 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 K010954 (2001). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K221951: Branchor Balloon Guide Catheter, Asahi Intecc Co., Ltd. (2022) Summary page 5.

## Indications for use
The Branchor X Balloon Guide Catheter is indicated for use to facilitate the insertion and guidance of an intravascular catheter into a selected blood vessel in the neuro vasculature, and injection of contrast media. The balloon provides temporary vascular occlusion during these procedures. The Branchor X Balloon Guide Catheter can also be used as a conduit for retrieval devices.

Source page: https://510kreport.com/device/K251240
Methodology: https://510kreport.com/methodology