510(k) K163268

FlexCath Select Steerable Shealth and Dilator by Medtronic Cryocath, LP — Product Code DYB

K163268 is an FDA 510(k) premarket notification submitted by Medtronic Cryocath, LP for the device "FlexCath Select Steerable Shealth and Dilator". The FDA issued a decision of Substantially Equivalent on February 2, 2017. The device falls under product code DYB (Introducer, Catheter), a Class II device regulated under 21 CFR 870.1340. Medtronic Cryocath, LP has at least 5 other 510(k) clearances on record.