# K261849: VERAFEYE Imaging Catheter (VF-VIC-002)

- Pathway: 510(k) (Special)
- Applicant: Luma Vision Limited
- Decided: Jul 24, 2026 after 51 days
- Product code: OBJ (Catheter, Ultrasound, Intravascular)
- Device class: 2
- Regulation: 21 CFR 870.1200
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 31 generations back to K935595 (1995). 265 ancestors in all.
No later device cites it as a predicate yet.
0 of 266 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K242893: VERAFEYE System VERAFEYE Imaging Catheter & VERAFEYE Imaging System, Luma Vision Limited (2025) Summary page 6.

## Indications for use
The VERAFEYE Imaging catheter is intended for intracardiac and intra-luminal visualization of cardiac and great vessel anatomy and physiology as well as visualization of other devices in the heart of adult patients. The catheter is intended for imaging guidance only, not treatment delivery, during cardiac interventional percutaneous procedures.

Source page: https://510kreport.com/device/K261849
Methodology: https://510kreport.com/methodology