# K223022: SC HONKYTONK PTCA Balloon Dilatation Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Sino Medical Sciences Technology, Inc.
- Decided: Feb 15, 2023 after 139 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 P860019 (1986). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K163174: Emerge PTCA Dilatation Catheter, Boston Scientific Corporation (2016) Summary page 4.

## Indications for use
The SC HONKYTONK PTCA Balloon Dilatation Catheter is indicated for the balloon catheter dilatation of the stenotic portion of a coronary artery or bypass graft stenosis for the purpose of improving myocardial perfusion.

Source page: https://510kreport.com/device/K223022
Methodology: https://510kreport.com/methodology