# K212393: OPN NC PTCA Dilatation Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Sis Medical AG
- Decided: Mar 14, 2022 after 224 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: 2 generations back to P790017 (1980). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K141090: NC Euphora Rapid Exchange Balloon Dilatation Catheter, Medtronic, Inc. (2014) Summary page 4.

## Indications for use
The OPN NC PTCA Dilatation Catheter is intended for balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis for the purpose of improving myocardial perfusion. The balloon dilatation catheter is also indicated for post deployment expansion of balloon expandable coronary stents.

Source page: https://510kreport.com/device/K212393
Methodology: https://510kreport.com/methodology