510(k) K183174

FlexCath Advance Steerable Sheath and Dilator by Medtronic Cryocath, LP — Product Code DRA

K183174 is an FDA 510(k) premarket notification submitted by Medtronic Cryocath, LP for the device "FlexCath Advance Steerable Sheath and Dilator". The FDA issued a decision of Substantially Equivalent on November 26, 2018. The device falls under product code DRA (Catheter, Steerable), a Class II device regulated under 21 CFR 870.1280. Medtronic Cryocath, LP has at least 5 other 510(k) clearances on record.