510(k) K163264

Pantheris Catheter (8F); Pantheris Cather (7F); Lightbox HS Imaging Console; Lightbox Sled by Avinger, Inc. — Product Code MCW

K163264 is an FDA 510(k) premarket notification submitted by Avinger, Inc. for the device "Pantheris Catheter (8F); Pantheris Cather (7F); Lightbox HS Imaging Console; Lightbox Sled". The FDA issued a decision of Substantially Equivalent on December 21, 2016. The device falls under product code MCW (Catheter, Peripheral, Atherectomy), a Class II device regulated under 21 CFR 870.4875. Avinger, Inc. has at least 10 other 510(k) clearances on record.