Clearance Summary
NES Reprocessed Eagle Eye Platinum RX Digital IVUS Catheter received FDA 510(k) clearance under submission number K223026, sponsored by Northeast Scientific, 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 2023-02-03.
- Submission: K223026
- Applicant / Sponsor: Northeast Scientific, Inc.
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.1200
- Decision date: 2023-02-03
Classification & Regulation
This clearance is catalogued under FDA product code OWQ and 21 CFR 870.1200, within the Cardiovascular review panel as a Class II device.