Clearance Summary
AcQMap 3D Imaging and Mapping Catheter, Model 900009 received FDA 510(k) clearance under submission number K210766, sponsored by Acutus Medical, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 2022-06-21.
- Submission: K210766
- Applicant / Sponsor: Acutus Medical, Inc.
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.1220
- Decision date: 2022-06-21
Classification & Regulation
This clearance is catalogued under FDA product code MTD and 21 CFR 870.1220, within the Cardiovascular review panel as a Class II device.