Clearance Summary
CARTO 3 EP Navigation System Software V8.0 (FG-5400-00, FG-5400-00U) received FDA 510(k) clearance under submission number K231207, sponsored by Biosense Webster, 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 2023-09-07.
- Submission: K231207
- Applicant / Sponsor: Biosense Webster, Inc.
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.1425
- Decision date: 2023-09-07
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.