Clearance Summary
NES Reprocessed 0.9mm Turbo Elite Laser Atherectomy Catheter received FDA 510(k) clearance under submission number K220171, 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 2022-07-01.
- Submission: K220171
- Applicant / Sponsor: Northeast Scientific, Inc.
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.4875
- Decision date: 2022-07-01
Classification & Regulation
This clearance is catalogued under FDA product code QTF and 21 CFR 870.4875, within the Cardiovascular review panel as a Class II device.