510(k) K163031

Bunegin-Albin Air Aspiration Set by Cook Incorporated — Product Code DXE

K163031 is an FDA 510(k) premarket notification submitted by Cook Incorporated for the device "Bunegin-Albin Air Aspiration Set". The FDA issued a decision of Substantially Equivalent on July 27, 2017. The device falls under product code DXE (Catheter, Embolectomy), a Class II device regulated under 21 CFR 870.5150. Cook Incorporated has at least 10 other 510(k) clearances on record.