# K173894: Jade PTA Balloon Dilatation Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Orbusneich Medical Trading, Inc.
- Decided: Feb 9, 2018 after 50 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). 9 ancestors in all.
3 later devices descend from it; 2 cite it directly.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K141150: Pta Balloon Dilatation Catheter, Boston Scientific Corp (2014) Summary page 4.

## Most influential descendants
- K202231: JADE (2020), 1 descendant of its own
- K201794: Jade (2020), 1 descendant of its own
- K241025: JADE PLUS PTA Balloon Dilatation Catheter (2024), 0 descendants of its own

## Indications for use
The Jade 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/K173894
Methodology: https://510kreport.com/methodology