K261119
- 510(k) number
- K261119
- Device name
- NorthStar Mapping System (MAP01 or MAP01-01)
- Applicant
- Imricor Medical Systems, Inc. MN · US
- Product code
- DQK — Computer, Diagnostic, Programmable
- Decision date
- 2026-06-30
- Date received
- 2026-04-03
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- Cardiovascular
PDFDownload 510(k) SummaryArchived here · 1.1 MB · U.S. public domain
Also available from FDA: K261119.pdf
Official FDA record: K261119
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.