BLUperc Percutaneous Dilation Tracheostomy Kit with BLUselect tube, BLUperc Percutaneous Dilation Tracheostomy Kit with BLUselect Suctionaid tube, BLUgriggs Percutaneous Dilation Tracheostomy Kit with BLUselect tube, BLUgriggs Percutaneous Dilation Tracheostomy Kit with BLUselect Suctionaid tube

About This 510(k) Submission

K173912 is an FDA 510(k) clearance for the BLUperc Percutaneous Dilation Tracheostomy Kit with BLUselect tube, BLUperc Percutaneous Dilation Tracheostomy Kit with BLUselect Suctionaid tube, BLUgriggs Percutaneous Dilation Tracheostomy Kit with BLUselect tube, BLUgriggs Percutaneous Dilation Tracheostomy Kit with BLUselect Suctionaid tube, a Tube Tracheostomy And Tube Cuff (Class II — Special Controls, product code JOH), submitted by Smiths Medical Asd, Inc. (Plymouth, US). The FDA issued a Cleared decision on May 8, 2018, 137 days after receiving the submission on December 22, 2017. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5800.