Clearance Summary
FlowTriever Retrieval/Aspiration System, FlowTriever Catheters, Triever 16, Triever 20, Triever 20 Curve, Triever 24 received FDA 510(k) clearance under submission number K211013, sponsored by Inari Medical, Inc.. The device was reviewed via the Special premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 2021-04-30.
- Submission: K211013
- Applicant / Sponsor: Inari Medical, Inc.
- Clearance pathway: Special
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.5150
- Decision date: 2021-04-30
Classification & Regulation
This clearance is catalogued under FDA product code QEW and 21 CFR 870.5150, within the Cardiovascular review panel as a Class II device.