# K221951: Branchor Balloon Guide Catheter

- Pathway: 510(k) (Special)
- Applicant: Asahi Intecc Co., Ltd.
- Decided: Oct 11, 2022 after 98 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 K010954 (2001). 4 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K203723: Branchor Balloon Guide Catheter, Asahi Intecc Co., Ltd. (2021) Summary page 4.

## Most influential descendants
- K251240: Branchor X Balloon Guide Catheter (2025), 0 descendants of its own

## Indications for use
The Branchor 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 Balloon Guide Catheter can also be used as a conduit for retrieval devices.

Source page: https://510kreport.com/device/K221951
Methodology: https://510kreport.com/methodology