510(k) K171600

Renal Access Cobra Catheter, Kumpe Access Catheter by Cook Incorporated — Product Code KOD

K171600 is an FDA 510(k) premarket notification submitted by Cook Incorporated for the device "Renal Access Cobra Catheter, Kumpe Access Catheter". The FDA issued a decision of Substantially Equivalent on February 16, 2018. The device falls under product code KOD (Catheter, Urological), a Class II device regulated under 21 CFR 876.5130. Cook Incorporated has at least 10 other 510(k) clearances on record.