# K162209: Sapphire NC Plus

- Pathway: 510(k) (Special)
- Applicant: Orbusneich Medical, Inc.
- Decided: Oct 6, 2016 after 62 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: 2 generations back to P790017 (1980). 5 ancestors in all.
9 later devices descend from it; 3 cite it directly.
0 of 15 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K103808: Sapphire NC, Orbusneich Medical, Inc. (2011) Summary page 4.

## Most influential descendants
- K163114: Sapphire II PRO (2017), 4 descendants of its own
- K192344: Sapphire NC Plus Coronary Dilatation Catheter (2019), 3 descendants of its own
- K211807: Sapphire NC 24 (2021), 1 descendant of its own
- K173680: Sapphire II PRO (2018), 1 descendant of its own
- K233499: Sapphire NC ULTRA Coronary Dilatation Catheter (2024), 0 descendants of its own

## Indications for use
The Sapphire NC Plus 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 Note: The subject device was tested on the bench with the OrbusNeich Blazer Cobalt-Chromium (CoCr) Alloy Stent. All stents should be deployed in accordance with the manufacturer’s indications and instructions for use.

Source page: https://510kreport.com/device/K162209
Methodology: https://510kreport.com/methodology