# K232245: VedDilator ^TM (3-Stage Balloon Dilation Catheter)

- Pathway: 510(k) (Traditional)
- Applicant: Jiangsu Vedkang Medical Science and Technology Co., Ltd.
- Decided: Feb 15, 2024 after 202 days
- Product code: FGE (Stents, Drains And Dilators For The Biliary Ducts)
- Device class: 2
- Regulation: 21 CFR 876.5010
- 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 K974788 (1998). 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)
- K112994: Cre Ditatation Ballon, Boston Scientific Corporation (2012) Summary page 5.

## Indications for use
It is indicated for use in adult and adolescent populations to endoscopically dilate or auxiliary dilate strictures of the alimentary tract.

Source page: https://510kreport.com/device/K232245
Methodology: https://510kreport.com/methodology