ClearanceBrief
510(k) K091761 ยท BTR Tube, Tracheal (W/Wo Connector)

TELEFLEX ISIS HVT TRACHEAL TUBE, CUFFED, WITH SUBGLOTTIC SECRETION SUCTION PORT

ApplicantTeleflexmedical, Inc., Durham NC, US
DecisionSubstantially Equivalent, Oct 29, 2009
ReceivedJun 16, 2009
TypeAbbreviated
FDA recordOpen on fda.gov

Recalls that name K091761

DateFirm and productCodeLinked 510(k)
Jul 30, 2019Centurion Medical Products Corporation
Sheridan Endotracheal Tube contained inside Centurion kit code TC7855.
Terminated
BTRNone listed
Feb 21, 2014Teleflex Medical
ISIS HVT Tracheal Tube Cuffed with Subglottic Secretion Suction Port, 6.0, Rx only, Product Usage: A tracheal tube is a device inserted into a patients trachea via the nose or mouth and used to main
Terminated
BTRNone listed
Feb 21, 2014Teleflex Medical
ISIS HVT Tracheal Tube Cuffed with Subglottic Secretion Suction Port, 6.5, Rx only, Product Usage: A tracheal tube is a device inserted into a patients trachea via the nose or mouth and used to maint
Terminated
BTRNone listed
Feb 21, 2014Teleflex Medical
ISIS HVT Tracheal Tube Cuffed with Subglottic Secretion Suction Port, 7.0, Rx only, Product Usage: A tracheal tube is a device inserted into a patients trachea via the nose or mouth and used to maint
Terminated
BTRNone listed
Feb 21, 2014Teleflex Medical
ISIS HVT Tracheal Tube Cuffed with Subglottic Secretion Suction Port, 7.5, Rx only, Product Usage: A tracheal tube is a device inserted into a patients trachea via the nose or mouth and used to main
Terminated
BTRNone listed
Feb 21, 2014Teleflex Medical
ISIS HVT Tracheal Tube Cuffed with Subglottic Secretion Suction Port, 8.0, Rx only, Product Usage: A tracheal tube is a device inserted into a patients trachea via the nose or mouth and used to mai
Terminated
BTRNone listed
Feb 21, 2014Teleflex Medical
ISIS HVT Tracheal Tube Cuffed with Subglottic Secretion Suction Port, 8.5, Rx only, Product Usage: A tracheal tube is a device inserted into a patients trachea via the nose or mouth and used to main
Terminated
BTRNone listed
Feb 21, 2014Teleflex Medical
ISIS HVT Tracheal Tube Cuffed with Subglottic Secretion Suction Port, 9.0, Rx only, Product Usage: A tracheal tube is a device inserted into a patients trachea via the nose or mouth and used to main
Terminated
BTRNone listed
Feb 21, 2014Teleflex Medical
ISIS HVT Tracheal Tube Cuffed with Subglottic Secretion Suction Port and Preloaded Stylet, 6.0, Rx only, Product Usage: A tracheal tube is a device inserted into a patients trachea via the nose or m
Terminated
BTRNone listed
Feb 21, 2014Teleflex Medical
ISIS HVT Tracheal Tube Cuffed with Subglottic Secretion Suction Port and Preloaded Stylet, 6.5, Rx only, Product Usage: A tracheal tube is a device inserted into a patients trachea via the nose or m
Terminated
BTRNone listed
Feb 21, 2014Teleflex Medical
ISIS HVT Tracheal Tube Cuffed with Subglottic Secretion Suction Port and Preloaded Stylet, 7.0, Rx only, Product Usage: A tracheal tube is a device inserted into a patients trachea via the nose or m
Terminated
BTRNone listed
Feb 21, 2014Teleflex Medical
ISIS HVT Tracheal Tube Cuffed with Subglottic Secretion Suction Port and Preloaded Stylet, 7.5, Rx only, Product Usage: A tracheal tube is a device inserted into a patients trachea via the nose or m
Terminated
BTRNone listed
Feb 21, 2014Teleflex Medical
ISIS HVT Tracheal Tube Cuffed with Subglottic Secretion Suction Port and Preloaded Stylet, 8.0, Rx only, Product Usage: A tracheal tube is a device inserted into a patients trachea via the nose or m
Terminated
BTRNone listed
Feb 21, 2014Teleflex Medical
ISIS HVT Tracheal Tube Cuffed with Subglottic Secretion Suction Port and Preloaded Stylet, 8.5, Rx only, Product Usage: A tracheal tube is a device inserted into a patients trachea via the nose or m
Terminated
BTRNone listed
Feb 21, 2014Teleflex Medical
ISIS HVT Tracheal Tube Cuffed with Subglottic Secretion Suction Port and Preloaded Stylet, 9.0, Rx only, Product Usage: A tracheal tube is a device inserted into a patients trachea via the nose or m
Terminated
BTRNone listed

Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.