Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3016481619

FEI Number

3016481619

Entity Name

VENA MEDICAL HOLDINGS CORP.

City/State/Country

Kitchener Ontario, CA

Establishment Address

809 Wellington Street North, Unit 2, Kitchener Ontario N2H 5L6, CA

Establishment Type(s)

Manufacture Medical Device,Complaint File Establishment per 21 CFR 820.198

Owner / Operator

Vena Medical Holdings Corp. (Owner Number: 10094056)

Owner / Operator Contact Address

809 Wellington Street North, Unit 2, Kitchener, CA-ON N2H 5L6, CA

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K251767

PMA Number

N/A

All Registered Proprietary Names

Vena MicroAngioscope System Vena MicroAngioscope System

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
LYK	Angioscope	Gastroenterology, Urology	Class 2	876.1500	2026-02-22
LYK	Angioscope	Gastroenterology, Urology	Class 2	876.1500	2025-11-14

Official Correspondent

Joseph De Croos

US Agent Details

Scott Bednar Business: QA/RA CONSULTING GROUP, INC. Email: sbednar@qaraconsultinggroup.com Phone: (412) 4188066

Related Public Records

Same Entity

Vena Medical Holdings Corp.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K924554	Clarus Medical Systems, Inc.	CLARUS SERIRS 2200 SEMI-RIGID ENDOSCOPE	1993-02-25

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3016481619. Last updated year: 2026. Please use registration number 3016481619 when referencing this establishment in official correspondence.