# K233505: Sapphire ULTRA Coronary Dilatation Catheter

- Pathway: 510(k) (Traditional)
- Applicant: OrbusNeich Medical (Shenzhen) Co., Ltd.
- Decided: Aug 15, 2024 after 289 days
- Product code: LOX (Catheters, Transluminal Coronary Angioplasty, Percutaneous)
- Device class: 2
- Regulation: 21 CFR 870.5100
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to P860019 (1986). 14 ancestors in all.
No later device cites it as a predicate yet.
0 of 15 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K173680: Sapphire II PRO, Orbusneich Medical Trading, Inc. (2018) Summary page 4.

## Indications for use
The Sapphire ULTRA Coronary Dilatation Catheter (1.0-1.25mm configurations) is indicated for: balloon pre-dilatation of a stenotic portion of a coronary artery or bypass graft stenosis (=70% stenosis) for the purpose of improving myocardial perfusion. The Sapphire ULTRA Coronary Dilatation Catheter (1.5-4.0mm configurations) is indicated for: balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis in patients evidencing coronary ischemia for the purpose of improving myocardial perfusion. balloon dilatation of a coronary artery occlusion for the treatment of acute myocardial infarction.

Source page: https://510kreport.com/device/K233505
Methodology: https://510kreport.com/methodology