# K230374: Coronary Dilatation Balloon Catheter (VesPenetrator®), Coronary Dilatation Balloon Catheter (VesTraveler®), Coronary Dilatation Balloon Catheter (VexPander®)

- Pathway: 510(k) (Traditional)
- Applicant: Dongguan TT Medical, Inc.
- Decided: Jun 29, 2023 after 136 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). 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)
- K103808: Sapphire NC, Orbusneich Medical, Inc. (2011) Summary page 4.

## Indications for use
The VesPenetrator®, VesTraveler® Coronary Dilatation Balloon Catheters are 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 The VexPander® Coronary Dilatation Balloon Catheters are 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/K230374
Methodology: https://510kreport.com/methodology