510(k) K171866

Sentrant Introducer Sheath with Hydrophilic Coating by Medtronic Vascular, Inc. — Product Code DYB

K171866 is an FDA 510(k) premarket notification submitted by Medtronic Vascular, Inc. for the device "Sentrant Introducer Sheath with Hydrophilic Coating". The FDA issued a decision of Substantially Equivalent on December 20, 2017. The device falls under product code DYB (Introducer, Catheter), a Class II device regulated under 21 CFR 870.1340. Medtronic Vascular, Inc. has at least 10 other 510(k) clearances on record.