# K202578: KardiFlex NC Coronary Dilatation Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Medcaptain Life Science Co., Ltd.
- Decided: May 6, 2021 after 240 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: 4 generations back to P790017 (1980). 7 ancestors in all.
No later device cites it as a predicate yet.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K192344: Sapphire NC Plus Coronary Dilatation Catheter, Orbusneich Medical Trading, Inc. (2019) Summary page 4.

## Indications for use
KardiFlex 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 ischemia 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.

Source page: https://510kreport.com/device/K202578
Methodology: https://510kreport.com/methodology