Clearance Summary
Solitaire Platinum Revascularization Device, Solitaire X Revascularization Device (Solitaire Revascularization Device) received FDA 510(k) clearance under submission number K193576, 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 2020-11-20.
- Submission: K193576
- 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: 2020-11-20
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.