510(k) Report

Devices descending from K861463

1 later device reach Shiley Sleep Apnea Low Pressure Cuffed Trach Tube through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K971267Shiley Extended Length, Disposable Cannula, Tracheostomy Tube: Cuffed, Distal Extension…Mallinckrodt Medical19970—