# K173680: Sapphire II PRO

- Pathway: 510(k) (Traditional)
- Applicant: Orbusneich Medical Trading, Inc.
- Decided: Mar 1, 2018 after 90 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 P860019 (1986). 13 ancestors in all.
1 later device descends from it; 1 cites 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)
- K163114: Sapphire II PRO, Orbusneich Medical, Inc. (2017) Summary page 4.
- K110617: Mini Trek RX 1.20 MM Coronary Dilatation Catheter, Mini Trek Otw 1.20 MM Coronary Dilatation Catheter, Abbott Vascular (2011) Summary page 4.
- K130391: Emerge Monorail Ptca Dilatation Catheter, Emerge Push Monorail Ptca Dilatation Catheter, Emerge Over-the-Wire Ptca Dilat, Boston Scientific Corp (2013) Summary page 4.
- K103095: Sprinter Legend 1.25MM RX and Sprinter Legend 1.25MM Otw Balloon, Medtronic, Ireland (2010) Summary page 4.

## Most influential descendants
- K233505: Sapphire ULTRA Coronary Dilatation Catheter (2024), 0 descendants of its own

## Indications for use
The Sapphire Il PRO 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 purposes of improving myocardial perfusion.

Source page: https://510kreport.com/device/K173680
Methodology: https://510kreport.com/methodology