# K211807: Sapphire NC 24

- Pathway: 510(k) (Traditional)
- Applicant: OrbusNeich Medical (Shenzhen) Co., Ltd.
- Decided: Oct 14, 2021 after 125 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: 4 generations back to P790017 (1980). 7 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K162209: Sapphire NC Plus, Orbusneich Medical, Inc. (2016) Summary page 5.
- K192344: Sapphire NC Plus Coronary Dilatation Catheter, Orbusneich Medical Trading, Inc. (2019) Summary page 5.

## Most influential descendants
- K233499: Sapphire NC ULTRA Coronary Dilatation Catheter (2024), 0 descendants of its own

## Indications for use
The Sapphire NC 24 Coronary Dilatation Catheter 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 in-stent restenosis post-delivery expansion of balloon expandable coronary stents

Source page: https://510kreport.com/device/K211807
Methodology: https://510kreport.com/methodology