# K163114: Sapphire II PRO

- Pathway: 510(k) (Traditional)
- Applicant: Orbusneich Medical, Inc.
- Decided: Jan 5, 2017 after 59 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: 3 generations back to P790017 (1980). 7 ancestors in all.
4 later devices descend from it; 3 cite it directly.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K103657: Sapphire, Orbusneich Medical, Inc. (2011) Summary page 4.
- K103808: Sapphire NC, Orbusneich Medical, Inc. (2011) Summary page 4.
- K162209: Sapphire NC Plus, Orbusneich Medical, Inc. (2016) Summary page 4.

## Most influential descendants
- K173680: Sapphire II PRO (2018), 1 descendant of its own
- K233505: Sapphire ULTRA Coronary Dilatation Catheter (2024), 0 descendants of its own
- K202619: KardiFlex PTCA Balloon Dilatation Catheter (2021), 0 descendants of its own
- K182699: Selethru PTCA Balloon Dilatation Catheter (2018), 0 descendants of its own

## Indications for use
The Sapphire II PRO 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

Source page: https://510kreport.com/device/K163114
Methodology: https://510kreport.com/methodology