Coronary Dilatation Balloon Catheter (VesPenetrator®), Coronary Dilatation Balloon Catheter (VesTraveler®), Coronary Dilatation Balloon Catheter (VexPander®)— 510(k) K230374

Substantially Equivalent

Dongguan TT Medical, Inc.

FDA 510(k) clearance K230374 for Coronary Dilatation Balloon Catheter (VesPenetrator®), Coronary Dilatation Balloon Catheter (VesTraveler®), Coronary Dilatation Balloon Catheter (VexPander®), Substantially Equivalent on 2023-06-29. Applicant: Dongguan TT Medical, Inc..

Clearance details

Applicant: Dongguan TT Medical, Inc.
Product code: Code LOX
Advisory panel: Cardiovascular
Date received: 2023-02-13
Decision date: 2023-06-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Dongguan, CN

Download summary PDF View on FDA.gov ↗

Adverse events under product code LOX

product code LOX

Death: 190
Injury: 1,498
Malfunction: 9,670
Total: 11,358

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.