# K213578: Balloon Dilatation Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Hangzhou AGS MedTech Co., Ltd.
- Decided: Apr 6, 2022 after 147 days
- Product code: FDF (Colonoscope And Accessories, Flexible/Rigid)
- Device class: 2
- Regulation: 21 CFR 876.1500
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K974788 (1998). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K110833: Cre Balloon Dilatation Catheter, Boston Scientific Corporation (2011) Summary page 4.

## Indications for use
The Balloon Dilatation Catheter is intended to endoscopically dilate strictures of the alimentary tract. The device is supplied sterile and intended for single use only.

Source page: https://510kreport.com/device/K213578
Methodology: https://510kreport.com/methodology