Clearance Summary
Trevo Pro Vue Retriever and Trevo XP Pro Vue Retriever (Trevo Retriever) received FDA 510(k) clearance under submission number K173352, sponsored by Concentric Medical, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Neurology review panel. The statutory decision date of record is 2018-02-15.
- Submission: K173352
- Applicant / Sponsor: Concentric Medical, Inc.
- Clearance pathway: Traditional
- Review panel: Neurology
- Device class: Class II
- Regulation citation: 21 CFR 882.5600
- Decision date: 2018-02-15
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.