# K103657: Sapphire

- Pathway: 510(k) (Traditional)
- Applicant: Orbusneich Medical, Inc.
- Decided: Aug 9, 2011 after 237 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: 1 generation back to P790017 (1980). 4 ancestors in all.
5 later devices descend from it; 1 cites it directly.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- P790017: Usci Dilatation Catheter, Medtronic, Ireland (1980) Summary page 1.
- P810046: Simpson-Robert Coronary Balloon Dilatation Cathete, Advanced Cardiovascular Systems, Inc. (1982) Summary page 1.
- P860019: Scimed Ptca Dilatation Catheter, Scimed Life Systems, Inc. (1986) Summary page 1.
- P880003: Cordis Ptca Dilatation Catheter, Cordis Corp. (1988) Summary page 1.

## Most influential descendants
- K163114: Sapphire II PRO (2017), 4 descendants of its own
- 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 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/K103657
Methodology: https://510kreport.com/methodology