# K251767: Vena MicroAngioscope™ System

- Pathway: 510(k) (Traditional)
- Applicant: Vena Medical Holdings Corp
- Decided: Oct 1, 2025 after 113 days
- Product code: LYK (Angioscope)
- Device class: 2
- Regulation: 21 CFR 876.1500
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K911278 (1991). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K911278: Olympus AF Angioscope System, Olympus Corp. (1991) Summary page 5.

## Indications for use
The Vena MicroAngioscope TM System is indicated for the observation of the interior of blood vessels of the peripheral vasculature.

Source page: https://510kreport.com/device/K251767
Methodology: https://510kreport.com/methodology