510(k) K172236

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

K172236 is an FDA 510(k) premarket notification submitted by Avinger, Inc. for the device "Pantheris Catheter (8F), Pantheris Catheter (7F), Lightbox HS Imaging Console, Lightbox Sled". The FDA issued a decision of Substantially Equivalent on October 30, 2017. 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.