510(k) K181757

Günther Tulip® Vena Cava Filter Retrieval Set by Cook Incorporated — Product Code MMX

K181757 is an FDA 510(k) premarket notification submitted by Cook Incorporated for the device "Günther Tulip® Vena Cava Filter Retrieval Set". The FDA issued a decision of Substantially Equivalent on November 6, 2018. The device falls under product code MMX (Device, Percutaneous Retrieval), a Class II device regulated under 21 CFR 870.5150. Cook Incorporated has at least 10 other 510(k) clearances on record.