Data / Medical devices / Canada / Front Line Medical Technologies Inc.
Front Line Medical Technologies Inc.: FDA-registered device maker in Toronto Ontario, Canada, 2 510(k) clearances
Front Line Medical Technologies Inc. is registered with the FDA (registration 3018565086) in Toronto Ontario, Canada. It lists 2 device types. The FDA files 2 510(k) clearances under its listings, the newest dated February 22, 2021. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3018565086
- Address
- 2 Bloor Street West, Suite 700, Toronto Ontario, Canada, M4W 3E2
- Owner or operator
- Front Line Medical Technologies Inc. (10083752)
- Roles
- Complaint file establishment, Repackager or relabeler, Specification developer
- First device listed
- December 16, 2021
- Registered through
- 2026
- Brand names listed
- COBRA-OS, COBRA-OS Custom Sheath Introducer Kit
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Catheter, Intravascular Occluding, Temporary | MJN | 2 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Dilator, Vessel, For Percutaneous Catheterization | DRE | 2 | Repackager or relabeler | 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 |
|---|---|---|---|---|---|---|
| February 22, 2021 | K201652 | COBRA-OS Kit | MJN | Unknown | Front Line Medical Technologies, Inc. | accessdata.fda.gov |
| November 20, 2007 | K073035 | PRELUDE AND PRELUDE PRO SHEATH INTRODUCERS | DRE | Substantially Equivalent | Merit Medical Systems, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Catheter, Intravascular Occluding, Temporary
- All makers of Dilator, Vessel, For Percutaneous Catheterization
Updated February 22, 2021. 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.