# K103808: Sapphire NC

- Pathway: 510(k) (Traditional)
- Applicant: Orbusneich Medical, Inc.
- Decided: Sep 1, 2011 after 246 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.
11 later devices descend from it; 3 cite it directly.
0 of 16 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). The summary prints P790017, a PMA number, which our reading took as K790017. Corrected to the number the summary prints. Summary page 1.
- P810046: Simpson-Robert Coronary Balloon Dilatation Cathete, Advanced Cardiovascular Systems, Inc. (1982). The summary prints P810046, a PMA number, which our reading took as K810046. Corrected to the number the summary prints. Summary page 1.
- P860019: Scimed Ptca Dilatation Catheter, Scimed Life Systems, Inc. (1986). The summary prints P860019, a PMA number, which our reading took as K860019. Corrected to the number the summary prints. Summary page 1.
- P880003: Cordis Ptca Dilatation Catheter, Cordis Corp. (1988). The summary prints P880003, a PMA number, which our reading took as K880003. Corrected to the number the summary prints. Summary page 1.

## Most influential descendants
- K162209: Sapphire NC Plus (2016), 9 descendants of its own
- 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

## Indications for use
The Sapphire NC Coronary Dilatation Catheter is indicated for: * balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis in patients evidencing coronary ischemnia 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/K103808
Methodology: https://510kreport.com/methodology