Clearance Summary
RAP Femoral Venous Cannulae received FDA 510(k) clearance under submission number K250283, sponsored by LivaNova USA, 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 2025-07-10.
- Submission: K250283
- Applicant / Sponsor: LivaNova USA, Inc.
- Clearance pathway: Special
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.4210
- Decision date: 2025-07-10
Classification & Regulation
This clearance is catalogued under FDA product code DWF and 21 CFR 870.4210, within the Cardiovascular review panel as a Class II device.