Clearance Summary
8F Modified Sheath System received FDA 510(k) clearance under submission number K240529, sponsored by Route 92 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 2024-10-02.
- Submission: K240529
- Applicant / Sponsor: Route 92 Medical, Inc.
- Clearance pathway: Special
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.1250
- Decision date: 2024-10-02
Classification & Regulation
This clearance is catalogued under FDA product code QJP and 21 CFR 870.1250, within the Cardiovascular review panel as a Class II device.