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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Tube, Tracheostomy (W/Wo Connector)
510(k) Number K173384
Device Name BLUselect, non-fenestrated, BLUselect, non-fenestrated, cont, BLUselect, fenestrated, BLUselect Suctionaid, BLUpere Dilation Trachestomy Kit, without tube
Applicant
Smiths Medical ADS, Inc.
6000 Nathan Lane North
Minneapolis,  MN  55442
Applicant Contact Donna M. Semlak
Correspondent
Smiths Medical ADS, Inc.
6000 Nathan Lane North
Minneapolis,  MN  55442
Correspondent Contact Donna M. Semlak
Regulation Number868.5800
Classification Product Code
BTO  
Date Received10/30/2017
Decision Date 04/10/2018
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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