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
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Angioscope | LYK | 2 | Complaint file establishment, Manufacturer | accessdata.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.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| January 28, 2026 | K253842 | Vena MicroAngioscope System | LYK | Substantially Equivalent | Vena Medical Holdings Corp | accessdata.fda.gov |
| October 1, 2025 | K251767 | Vena MicroAngioscope System | LYK | Substantially Equivalent | Vena Medical Holdings Corp | accessdata.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.