510(k) K160593

Indy OTW Vascular Retriever by Cook Incorporated — Product Code MMX

K160593 is an FDA 510(k) premarket notification submitted by Cook Incorporated for the device "Indy OTW Vascular Retriever". The FDA issued a decision of Substantially Equivalent on September 2, 2016. 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.