Clearance Summary
NorthStar Mapping System (MAP01 or MAP01-01) received FDA 510(k) clearance under submission number K261119, sponsored by Imricor Medical Systems, Inc.. The device was reviewed via the Special premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 2026-06-30.
- Submission: K261119
- Applicant / Sponsor: Imricor Medical Systems, Inc.
- Clearance pathway: Special
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.1425
- Decision date: 2026-06-30
Classification & Regulation
This clearance is catalogued under FDA product code DQK and 21 CFR 870.1425, within the Cardiovascular review panel as a Class II device.