Clearance Summary
pRESET Delta Thrombectomy Device and pRESET Delta LITE Thrombectomy Device received FDA 510(k) clearance under submission number K242676, sponsored by Phenox Limited. The device was reviewed via the Special premarket notification pathway and assigned to the Neurology review panel. The statutory decision date of record is 2025-02-28.
- Submission: K242676
- Applicant / Sponsor: Phenox Limited
- Clearance pathway: Special
- Review panel: Neurology
- Device class: Class II
- Regulation citation: 21 CFR 882.5600
- Decision date: 2025-02-28
Classification & Regulation
This clearance is catalogued under FDA product code POL and 21 CFR 882.5600, within the Neurology review panel as a Class II device.