Vena Medical Holdings Corp · Class II · Cleared Jan 28, 2026
| K-number | K253842 |
| Device name | Vena MicroAngioscope System |
| Applicant | Vena Medical Holdings Corp |
| Product code | LYK |
| Device class | Class II |
| Decision date | Jan 28, 2026 |
| Decision | Substantially Equivalent |
| Regulation | 876.1500 |
The Vena MicroAngioscope System is an imaging angioscope consisting of a sterile, single-use MicroAngioscope probe and a reusable Camera Control Unit. It provides real-time, high-resolution visualization of blood vessels to enable diagnosis and intervention in peripheral and coronary vascular disease. The probe connects to the CCU to acquire images and transmit live video via HDMI for external display.
The subject device is a full-color, forward-viewing angioscope with a 127-degree field of view, 1600 mm working length, and 1.0 mm insertion tube diameter, compared to the predicate's 55-degree field of view, 1300 mm length, and 1.5 mm diameter. The subject uses integrated LED illumination and a high-resolution video endoscope, while the predicate uses fiberoptic bundles. Both are sterile single-use devices sterilized with ethylene oxide and feature a radiopaque marker band.
ISO 10993-1 (biocompatibility), ISO 11135:2014 (ethylene oxide sterilization), IEC 60601-1, IEC 60601-1-2, IEC 60601-2-18, IEC 60601-4-2 (electrical safety and EMC), and IEC 62304 (software validation). 21 CFR 820.30 (design controls) was followed for verification and validation.
View the full FDA submission: accessdata.fda.gov