Clearance Summary
pREBOA-PRO Catheter received FDA 510(k) clearance under submission number K243795, sponsored by Prytime Medical Devices, 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 2025-09-05.
- Submission: K243795
- Applicant / Sponsor: Prytime Medical Devices, Inc.
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.4450
- Decision date: 2025-09-05
Classification & Regulation
This clearance is catalogued under FDA product code MJN and 21 CFR 870.4450, within the Cardiovascular review panel as a Class II device.