# K223275: CELLO II Balloon Guide Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Fuji Systems Corporation
- Decided: Dec 9, 2022 after 46 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: 3 generations back to K010954 (2001). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K120781: Cello Balloon Guide Catheter (6F), 950 MM and 1020 MM Length, Fuji Systems Corp. (2012) Summary page 4.

## Indications for use
The CELLO II Balloon Guide Catheter is indicated for use in facilitating the insertion and guidance of intravascular catheters into a selected blood vessel in the peripheral and neuro vasculature systems. The balloon provides temporary vascular occlusion during these and other angiographic procedures.

Source page: https://510kreport.com/device/K223275
Methodology: https://510kreport.com/methodology