510(k) K171193

Certa Catheter by Ferrosan Medical Devices Sp. Z.O.O. — Product Code BSO

K171193 is an FDA 510(k) premarket notification submitted by Ferrosan Medical Devices Sp. Z.O.O. for the device "Certa Catheter". The FDA issued a decision of Substantially Equivalent on December 18, 2017. The device falls under product code BSO (Catheter, Conduction, Anesthetic), a Class II device regulated under 21 CFR 868.5120.