Clearance Summary
Intri26 Introducer Sheath received FDA 510(k) clearance under submission number K252508, sponsored by Inari Medical, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 2025-12-17.
- Submission: K252508
- Applicant / Sponsor: Inari Medical, Inc.
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.1340
- Decision date: 2025-12-17
Classification & Regulation
This clearance is catalogued under FDA product code DYB and 21 CFR 870.1340, within the Cardiovascular review panel as a Class II device.