Clearance Summary
Drivewire 35 Guidewire received FDA 510(k) clearance under submission number K254006, sponsored by Rapid Medical Ltd.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 2026-07-17.
- Submission: K254006
- Applicant / Sponsor: Rapid Medical Ltd.
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.1330
- Decision date: 2026-07-17
Classification & Regulation
This clearance is catalogued under FDA product code MOF and 21 CFR 870.1330, within the Cardiovascular review panel as a Class II device.