Clearance Summary
Hyperdrive 35 Guidewire received FDA 510(k) clearance under submission number K253146, 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 2026-09-18.
- Submission: K253146
- Applicant / Sponsor: Rapid-Medical , Ltd.
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.1330
- Decision date: 2026-09-18
Classification & Regulation
This clearance is catalogued under FDA product code DQX and 21 CFR 870.1330, within the Cardiovascular review panel as a Class II device.