Data / Medical devices / United States / Imricor Medical Systems
Imricor Medical Systems: FDA-registered device maker in Burnsville, MN, United States, 3 510(k) clearances
Imricor Medical Systems is registered with the FDA (registration 3009254201) in Burnsville, MN, United States. It lists 2 device types. The FDA files 3 510(k) clearances under its listings, the newest dated June 30, 2026. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 3009254201
- Address
- 400 Gateway Blvd, Burnsville, MN, United States, 55337
- Owner or operator
- Imricor Medical Systems (10095474)
- Roles
- Complaint file establishment, Manufacturer
- First device listed
- March 17, 2026
- Registered through
- 2027
- Brand names listed
- NorthStar Mapping System, Vision-MR® Diagnostic Catheter
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Catheter, Electrode Recording, Or Probe, Electrode Recording | DRF | 2 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| 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 |
|---|---|---|---|---|---|---|
| June 30, 2026 | K261119 | NorthStar Mapping System (MAP01 or MAP01-01) | DQK | Substantially Equivalent | Imricor Medical Systems, Inc. | accessdata.fda.gov |
| January 28, 2026 | K252164 | NorthStar Mapping System | DQK | Substantially Equivalent | Imricor Medical Systems | accessdata.fda.gov |
| January 8, 2026 | K252794 | Vision-MR Diagnostic Catheter | DRF | Substantially Equivalent | Imricor Medical Systems, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Computer, Diagnostic, Programmable
- All makers of Catheter, Electrode Recording, Or Probe, Electrode Recording
Updated June 30, 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.