Data / Medical devices / United States / Cardionxt
Cardionxt: FDA-registered device maker in Westminster, CO, United States, 1 510(k) clearance
Cardionxt is registered with the FDA (registration 3020036682) in Westminster, CO, United States. It lists 1 device type. The FDA files 1 510(k) clearance under its listings, the newest dated August 16, 2021. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3020036682
- Address
- 12011 N Tejon St Suite 700, Westminster, CO, United States, 80234
- Owner or operator
- CardioNXT (10050640)
- Roles
- Complaint file establishment, Manufacturer
- First device listed
- August 17, 2021
- Registered through
- 2026
- Brand names listed
- Axis Patient Patches, MultiLink CS Catheter, iMap 3d Mapping and Navigation System
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Computer, Diagnostic, Programmable | DQK | 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 |
|---|---|---|---|---|---|---|
| August 16, 2021 | K201094 | iMap 3D Mapping & Navigation System (iMap System) | DQK | Substantially Equivalent | Cardionxt, Inc. | accessdata.fda.gov |
Compare with other makers
Updated August 16, 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.