# K260416: ZYLOX Hippo PTA Balloon Dilatation Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Zylox Medtech Co., Ltd.
- Decided: Sep 21, 2026 after 224 days
- Product code: LIT (Catheter, Angioplasty, Peripheral, Transluminal)
- 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 K001134 (2000). 12 ancestors in all.
No later device cites it as a predicate yet.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K201170: Athletis PTA Balloon Dilatation Catheter, Boston Scientific Corporation (2020) Summary page 6.

## Indications for use
The ZYLOX Hippo PTA Balloon Dilatation Catheter is indicated for Percutaneous Transluminal Angioplasty. in the peripheral vasculature including upper extremity, renal, iliac, and infra-inguinal vessels and the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. The ZYLOX Hippo PTA Balloon Dilatation Catheter is also indicated for post-dilatation of stents and stent grafts in the peripheral vasculature.

Source page: https://510kreport.com/device/K260416
Methodology: https://510kreport.com/methodology