510(k) K180028

Cook 810 Set, Desilets-Hoffman Introducer Set by Cook Incorporated — Product Code EZN

K180028 is an FDA 510(k) premarket notification submitted by Cook Incorporated for the device "Cook 810 Set, Desilets-Hoffman Introducer Set". The FDA issued a decision of Substantially Equivalent on May 2, 2018. The device falls under product code EZN (Dilator, Catheter, Ureteral), a Class II device regulated under 21 CFR 876.5470. Cook Incorporated has at least 10 other 510(k) clearances on record.