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FDA 510(k)

VERAFEYE Imaging Catheter (VF-VIC-002)

K-Number: K261849 · 2026-07-24

Decision Date2026-07-24
Product CodeOBJ
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

VERAFEYE Imaging Catheter (VF-VIC-002) is the device name listed in this FDA 510(k) record. The listed applicant is Luma Vision Limited. It received FDA 510(k) clearance on 2026-07-24 under 510(k) number K261849. The device is classified under product code OBJ. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the VERAFEYE Imaging Catheter (VF-VIC-002)?

VERAFEYE Imaging Catheter (VF-VIC-002) is a medical device that received FDA 510(k) clearance on 2026-07-24. The listed applicant is Luma Vision Limited. The 510(k) number is K261849.

When did VERAFEYE Imaging Catheter (VF-VIC-002) receive FDA 510(k) clearance?

VERAFEYE Imaging Catheter (VF-VIC-002) received FDA 510(k) clearance on 2026-07-24, under 510(k) number K261849.

Who is the listed applicant for VERAFEYE Imaging Catheter (VF-VIC-002)?

The FDA 510(k) record lists Luma Vision Limited as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for VERAFEYE Imaging Catheter (VF-VIC-002)?

The FDA product code for VERAFEYE Imaging Catheter (VF-VIC-002) is OBJ.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

Other records listing Luma Vision Limited as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

Related Devices (Code: OBJ)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.