# K232437: Paragon 8F Balloon Guide Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Wallaby Medical
- Decided: Oct 13, 2023 after 60 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: 7 generations back to K010954 (2001). 7 ancestors in all.
No later device cites it as a predicate yet.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K153729: 8F FlowGate2 Balloon Guide Catheter, Concentric Medical (2016) Summary page 4.

## Indications for use
The Paragon 8F Balloon Guide Catheter is indicated for use in facilitating the insertion and guidance of an intravascular catheter into a selected blood vessel in the peripheral and neuro vascular systems. The balloon provides temporary vascular occlusion during these and other angiographic procedures. The Paragon 8F Balloon Guide Catheter is also indicated for use as a conduit for retrieval devices.

Source page: https://510kreport.com/device/K232437
Methodology: https://510kreport.com/methodology