510(k) K173384

BLUselect, non-fenestrated, BLUselect, non-fenestrated, cont, BLUselect, fenestrated, BLUselect Suctionaid, BLUpere Dilation Trachestomy Kit, without tube by Smiths Medical Ads, Inc. — Product Code BTO

K173384 is an FDA 510(k) premarket notification submitted by Smiths Medical Ads, Inc. for the device "BLUselect, non-fenestrated, BLUselect, non-fenestrated, cont, BLUselect, fenestrated, BLUselect Suctionaid, BLUpere Dilation Trachestomy Kit, without tube". The FDA issued a decision of Substantially Equivalent on April 10, 2018. The device falls under product code BTO (Tube, Tracheostomy (W/Wo Connector)), a Class II device regulated under 21 CFR 868.5800. Smiths Medical Ads, Inc. has at least 1 other 510(k) clearance on record.