Clearance Summary
Pantheris Catheter (8F); Pantheris Cather (7F); Lightbox HS Imaging Console; Lightbox Sled received FDA 510(k) clearance under submission number K163264, sponsored by Avinger, Inc.. The device was reviewed via the Special premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 2016-12-21.
- Submission: K163264
- Applicant / Sponsor: Avinger, Inc.
- Clearance pathway: Special
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.4875
- Decision date: 2016-12-21
Classification & Regulation
This clearance is catalogued under FDA product code MCW and 21 CFR 870.4875, within the Cardiovascular review panel as a Class II device.