Clearance Summary
Modified Trevo ProVue Retriever, Trevo XP ProVue Retriever 4x20mm, Trevo XP ProVue Retriever 3x20mm, Trevo XP ProVue Retriever 6x25mm, Trevo XP ProVue Retriever 4x30mm received FDA 510(k) clearance under submission number DEN150049, sponsored by Concentric Medical, Inc.. The device was reviewed via the Direct premarket notification pathway and assigned to the Neurology review panel. The statutory decision date of record is 2016-09-02.
- Submission: DEN150049
- Applicant / Sponsor: Concentric Medical, Inc.
- Clearance pathway: Direct
- Review panel: Neurology
- Device class: Class II
- Regulation citation: 21 CFR 882.5600
- Decision date: 2016-09-02
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.