Clearance Summary
ViewFlex Xtra ICE Catheter; ViewFlex Eco Reprocessed ICE Catheter; Advisor HD Grid Mapping Catheter, Sensor Enabled; Advisor HD Grid X Mapping Catheter, Sensor Enabled; Agilis NxT Steerable Introducer; Agilis NxT Steerable Introducer Dual-Reach received FDA 510(k) clearance under submission number K251211, sponsored by ABBOTT MEDICAL. The device was reviewed via the Special premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 2025-05-23.
- Submission: K251211
- Applicant / Sponsor: ABBOTT MEDICAL
- Clearance pathway: Special
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.1200
- Decision date: 2025-05-23
Classification & Regulation
This clearance is catalogued under FDA product code OBJ and 21 CFR 870.1200, within the Cardiovascular review panel as a Class II device.