Clearance Summary
Paladin Carotid Post-dilation Balloon System with Integrated Embolic Protection (Paladin System) received FDA 510(k) clearance under submission number K181128, sponsored by Contego Medical, LLC. The device was reviewed via the Traditional premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 2018-09-06.
- Submission: K181128
- Applicant / Sponsor: Contego Medical, LLC
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.1250
- Decision date: 2018-09-06
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.