Clearance Summary
Sublime Radial Access 018 RX Dilatation Catheter received FDA 510(k) clearance under submission number K211044, sponsored by Creagh Medical Ltd. (A Wholly Owned Subsidiary of Surmodics,. The device was reviewed via the Special premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 2021-06-16.
- Submission: K211044
- Applicant / Sponsor: Creagh Medical Ltd. (A Wholly Owned Subsidiary of Surmodics,
- Clearance pathway: Special
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.1250
- Decision date: 2021-06-16
Classification & Regulation
This clearance is catalogued under FDA product code LIT and 21 CFR 870.1250, within the Cardiovascular review panel as a Class II device.