510(k) K162326

Pantheris Catheter, Lightbix HS Imaging Console, Lightbox Sled by Avinger, Inc. — Product Code MCW

K162326 is an FDA 510(k) premarket notification submitted by Avinger, Inc. for the device "Pantheris Catheter, Lightbix HS Imaging Console, Lightbox Sled". The FDA issued a decision of Substantially Equivalent on October 18, 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.