510(k) K222254

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

K222254 is an FDA 510(k) premarket notification submitted by Cook Incorporated for the device "Gunther Tulip Vena Cava Filter Retrieval Set". The FDA issued a decision of Substantially Equivalent on May 16, 2023. 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.