K253842 is an FDA 510(k) clearance for the Vena MicroAngioscope? System. This device is classified as a Angioscope (Class II - Special Controls, product code LYK).
Submitted by Vena Medical Holdings Corp (Kitchener, CA). The FDA issued a Cleared decision on January 28, 2026, 57 days after receiving the submission on December 2, 2025.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 876.1500.
| 510(k) Number | K253842 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 02, 2025 |
| Decision Date | January 28, 2026 |
| Days to Decision | 57 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
| Product Code | LYK — Angioscope |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 876.1500 |