# K241025: JADE PLUS PTA Balloon Dilatation Catheter

- Pathway: 510(k) (Traditional)
- Applicant: OrbusNeich Medical (Shenzhen) Co., Ltd.
- Decided: Jun 11, 2024 after 57 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: 9 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)
- K202231: JADE, OrbusNeich Medical (Shenzhen) Co., Ltd. (2020) Summary page 5.
- K201794: Jade, OrbusNeich Medical (Shenzhen) Co., Ltd. (2020) Summary page 6.

## Indications for use
The JADE PLUS PTA Balloon Dilatation Catheter is indicated for Percutaneous Transluminal Angioplasty in the peripheral vasculature, including iliac, femoral, ilio-femoral, popliteal, infra-popliteal, and renal arteries, and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. This device is also indicated for post-dilation of balloon expandable and self-expanding stents in the peripheral vasculature.

Source page: https://510kreport.com/device/K241025
Methodology: https://510kreport.com/methodology