Clearance Summary
PENTARAY® NAV ECO High Density Mapping Catheter, DECANAV® Mapping Catheter, Webster® CS Catheter with Auto ID, Webster® CS Catheter with EZ Steer Technology, Webster® CS Catheter with EZ Steer Technology with Auto ID received FDA 510(k) clearance under submission number K231312, sponsored by Biosense Webster, 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 2023-07-10.
- Submission: K231312
- Applicant / Sponsor: Biosense Webster, Inc.
- Clearance pathway: Special
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.1220
- Decision date: 2023-07-10
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.