Clearance Summary
Axium Detachable Coil; Axium Prime Detachable Coil received FDA 510(k) clearance under submission number K233420, sponsored by Micro Therapeutics Lnc. D/B/A Ev3 Neurovascular. The device was reviewed via the Special premarket notification pathway and assigned to the Neurology review panel. The statutory decision date of record is 2023-11-07.
- Submission: K233420
- Applicant / Sponsor: Micro Therapeutics Lnc. D/B/A Ev3 Neurovascular
- Clearance pathway: Special
- Review panel: Neurology
- Device class: Class II
- Regulation citation: 21 CFR 882.5950
- Decision date: 2023-11-07
Classification & Regulation
This clearance is catalogued under FDA product code HCG and 21 CFR 882.5950, within the Neurology review panel as a Class II device.