# K200269: Sapphire II PRO

- Pathway: 510(k) (Special)
- Applicant: Orbusneich Medical Trading, Inc.
- Decided: Mar 4, 2020 after 29 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: 5 generations back to K042537 (2004). 8 ancestors in all.
No later device cites it as a predicate yet.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K180921: Sapphire II PRO Balloon Dilatation Catheter, Orbusneich Medical Trading, Inc. (2018) Summary page 4.

## Indications for use
The Sapphire® II PRO balloon 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 purpose of improving myocardial perfusion. The Sapphire® II PRO balloon dilatation catheter (1.5-4.0mm configurations) 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. The Sapphire® II PRO balloon dilatation catheter is also indicated for: • percutaneous transluminal angioplasty in the peripheral vasculature, including renal, femoral, popliteal, infra-popliteal, tibial, and peroneal arteries.

Source page: https://510kreport.com/device/K200269
Methodology: https://510kreport.com/methodology