Clearance Summary
Solitaire X Revascularization Device received FDA 510(k) clearance under submission number K203358, sponsored by Micro Therapeutics, Inc. d/b/a ev3 Neurovascular. The device was reviewed via the Traditional premarket notification pathway and assigned to the Neurology review panel. The statutory decision date of record is 2021-03-01.
- Submission: K203358
- Applicant / Sponsor: Micro Therapeutics, Inc. d/b/a ev3 Neurovascular
- Clearance pathway: Traditional
- Review panel: Neurology
- Device class: Class II
- Regulation citation: 21 CFR 882.5600
- Decision date: 2021-03-01
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.