510(k) K172394

Steerable Guide Catheter by Abbott Vascular — Product Code DRA

K172394 is an FDA 510(k) premarket notification submitted by Abbott Vascular for the device "Steerable Guide Catheter". The FDA issued a decision of Substantially Equivalent on September 6, 2017. The device falls under product code DRA (Catheter, Steerable), a Class II device regulated under 21 CFR 870.1280. Abbott Vascular has at least 10 other 510(k) clearances on record.