BLUselect, non-fenestrated, BLUselect, non-fenestrated, cont, BLUselect, fenestrated, BLUselect Suctionaid, BLUpere Dilation Trachestomy Kit, without tube

About This 510(k) Submission

K173384 is an FDA 510(k) clearance for the BLUselect, non-fenestrated, BLUselect, non-fenestrated, cont, BLUselect, fenestrated, BLUselect Suctionaid, BLUpere Dilation Trachestomy Kit, without tube, a Tube, Tracheostomy (w/wo Connector) (Class II — Special Controls, product code BTO), submitted by Smiths Medical Ads, Inc. (Plymouth, US). The FDA issued a Cleared decision on April 10, 2018, 162 days after receiving the submission on October 30, 2017. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5800.