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Data / Medical devices / Canada / Vena Medical Holdings Corp.

Vena Medical Holdings Corp.: FDA-registered device maker in Kitchener Ontario, Canada, 2 510(k) clearances

Vena Medical Holdings Corp. is registered with the FDA (registration 3016481619) in Kitchener Ontario, Canada. It lists 1 device type. The FDA files 2 510(k) clearances under its listings, the newest dated January 28, 2026. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number
3016481619
Address
809 Wellington Street North Unit 2, Kitchener Ontario, Canada, N2H 5L6
Owner or operator
Vena Medical Holdings Corp. (10094056)
Roles
Complaint file establishment, Manufacturer
First device listed
November 14, 2025
Registered through
2026
Brand names listed
Vena MicroAngioscope System

Devices it lists

DeviceProduct codeClassRoleSource
AngioscopeLYK2Complaint file establishment, Manufactureraccessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided510(k) numberDeviceProduct codeDecisionApplicantSource
January 28, 2026K253842Vena MicroAngioscope™ SystemLYKSubstantially EquivalentVena Medical Holdings Corpaccessdata.fda.gov
October 1, 2025K251767Vena MicroAngioscope™ SystemLYKSubstantially EquivalentVena Medical Holdings Corpaccessdata.fda.gov

Compare with other makers

Updated January 28, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.