# K202619: KardiFlex PTCA Balloon Dilatation Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Medcaptain Life Science Co., Ltd.
- Decided: Apr 29, 2021 after 231 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). 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)
- K163114: Sapphire II PRO, Orbusneich Medical, Inc. (2017) Summary page 4.

## Indications for use
KardiFlex PTCA Balloon 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/K202619
Methodology: https://510kreport.com/methodology