Data / Medical devices / United States / Access Point Technologies, Ep Inc.
Access Point Technologies, Ep Inc.: FDA-registered device maker in Rogers, MN, United States, 2 510(k) clearances
Access Point Technologies, Ep Inc. is registered with the FDA (registration 3005402529) in Rogers, MN, United States. It lists 3 device types. The FDA files 2 510(k) clearances under its listings, the newest dated July 23, 2025. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 3005402529
- Address
- 12560 Fletcher Lane Suite 300, Rogers, MN, United States, 55374
- Owner or operator
- Stereotaxis (9048165)
- Roles
- Complaint file establishment, Manufacturer, Manufacturer for export
- First device listed
- February 21, 2025
- Registered through
- 2027
- Brand names listed
- Cable, Electrode, Catheter, Electrode recording, or probe, electrode recording, Catheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation, MAGiC Sweep EP Mapping Catheter
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Cable, Electrode | IKD | 2 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Catheter, Electrode Recording, Or Probe, Electrode Recording | DRF | 2 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation | OAE | 3 | Manufacturer for export | 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 |
|---|---|---|---|---|---|---|
| July 23, 2025 | K250590 | MAGiC Sweep EP Mapping Catheter | DRF | Substantially Equivalent | Stereotaxis, Inc. | accessdata.fda.gov |
| April 11, 2016 | K160390 | Map-it Diagnostic Mapping Catheters | DRF | Substantially Equivalent | Access Point Technologies Ep, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Catheter, Electrode Recording, Or Probe, Electrode Recording
- All makers of Cable, Electrode
- All makers of Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation
Updated July 23, 2025. 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.