Clearance Summary
NuVision ICE Catheter received FDA 510(k) clearance under submission number K201775, sponsored by Nuvera Medical, 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 2021-03-05.
- Submission: K201775
- Applicant / Sponsor: Nuvera Medical, Inc.
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.1200
- Decision date: 2021-03-05
Classification & Regulation
This clearance is catalogued under FDA product code OBJ and 21 CFR 870.1200, within the Cardiovascular review panel as a Class II device.