← Product Code [OBJ](/productcode/OBJ) · K261849

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

_Luma Vision Limited · OBJ · Jul 24, 2026 · Cardiovascular · SESE_

**Canonical URL:** https://fda.innolitics.com/device/K261849

## Device Facts

- **Applicant:** Luma Vision Limited
- **Product Code:** [OBJ](/productcode/OBJ.md)
- **Decision Date:** Jul 24, 2026
- **Decision:** SESE
- **Submission Type:** Special
- **Regulation:** 21 CFR 870.1200
- **Device Class:** Class 2
- **Review Panel:** Cardiovascular

## Regulatory Identification

An intravascular diagnostic catheter is a device used to record intracardiac pressures, to sample blood, and to introduce substances into the heart and vessels. Included in this generic device are right-heart catheters, left-heart catheters, and angiographic catheters, among others.

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**Source:** [https://fda.innolitics.com/device/K261849](https://fda.innolitics.com/device/K261849)

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