# K253842: Vena MicroAngioscope™ System

- Pathway: 510(k) (Traditional)
- Applicant: Vena Medical Holdings Corp
- Decided: Jan 28, 2026 after 57 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 K952638 (1995). 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)
- K952638: 4.5F Imagecath Coronary Angioscope, Model COV45 [Subsequently Referred to as the Modified Angioscope[, Baxter Edwards (1995) Summary page 5.

## Indications for use
The Vena MicroAngioscope™ System is indicated for the visualization and diagnosis of vascular disease within the peripheral and coronary vessels.

Source page: https://510kreport.com/device/K253842
Methodology: https://510kreport.com/methodology