Clearance Summary
Mirage Hydrophilic Guidewire, X-pedion Hydrophilic Guidewire received FDA 510(k) clearance under submission number K193548, sponsored by Micro Therapeutics, Inc. d/b/a ev3 Neurovascular. The device was reviewed via the Special premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 2020-01-18.
- Submission: K193548
- Applicant / Sponsor: Micro Therapeutics, Inc. d/b/a ev3 Neurovascular
- Clearance pathway: Special
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.1330
- Decision date: 2020-01-18
Classification & Regulation
This clearance is catalogued under FDA product code DQX and 21 CFR 870.1330, within the Cardiovascular review panel as a Class II device.