# K123473: Hoper Ptca Balloon Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Lepu Medical Technology (Beijing) Co., Ltd.
- Decided: Aug 13, 2013 after 273 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 P860019 (1986). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K110133: Empira RX Ptca Dilatation Catheter, Empria NC RX Ptca Dilatation Catheter, Creganna-Tactx Medical (2011)
- P880003: Cordis Ptca Dilatation Catheter, Cordis Corp. (1988) Summary page 1.
- P020037: FX Minirail RX Percutaneous Transluminal Coronary Angioplasty (Ptca) Catheter, Abbott Vascular, Inc. (2003) Summary page 1.

## Indications for use
The balloon dilatation catheter is indicated for balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis for the purpose of improving myocardial perfusion. This balloon dilatation catheter is not intended for the expansion or delivery of a stent.

Source page: https://510kreport.com/device/K123473
Methodology: https://510kreport.com/methodology