510(k) K961837 · BTR Tube, Tracheal (W/Wo Connector)

RUSH ORAL/NASAL TRACHEAL TUBE CUFFED MAGILL/MURPHY

Applicant	Rusch Intl., Jeffrey NH, US
Decision	Substantially Equivalent, Aug 16, 1996
Received	May 13, 1996
Type	Traditional
FDA record	Open on fda.gov

Recalls that name K961837

Date	Firm and product	Code	Linked 510(k)
Jun 29, 2023	TELEFLEX LLC Flexi-Set Cuffed Endotracheal Tube and Stylet Set, oral/nasal, REF 504550 Open, Classified	BTR	None listed
Jun 29, 2023	TELEFLEX LLC Flexi-Set Cuffed Endotracheal Tube and Stylet Set, oral/nasal, REF 504555 Open, Classified	BTR	None listed
Jun 29, 2023	TELEFLEX LLC Flexi-Set Cuffed Endotracheal Tube and Stylet Set, oral/nasal, REF 504560 Open, Classified	BTR	None listed
Jun 29, 2023	TELEFLEX LLC Flexi-Set Cuffed Endotracheal Tube and Stylet Set, oral/nasal, REF 504565 Open, Classified	BTR	None listed
Jun 29, 2023	TELEFLEX LLC Flexi-Set Cuffed Endotracheal Tube and Stylet Set, oral/nasal, REF 504570 Open, Classified	BTR	None listed
Jun 29, 2023	TELEFLEX LLC Flexi-Set Cuffed Endotracheal Tube and Stylet Set, oral/nasal, REF 504575 Open, Classified	BTR	None listed
Jun 29, 2023	TELEFLEX LLC Flexi-Set Cuffed Endotracheal Tube and Stylet Set, oral/nasal, REF 504580 Open, Classified	BTR	None listed
Jun 29, 2023	TELEFLEX LLC Flexi-Set Cuffed Endotracheal Tube and Stylet Set, oral/nasal, REF 504585 Open, Classified	BTR	None listed
Jun 29, 2023	TELEFLEX LLC Flexi-Set Cuffed Endotracheal Tube and Stylet Set, oral/nasal, REF 504590 Open, Classified	BTR	None listed
Jun 29, 2023	TELEFLEX LLC Endotracheal Tube oral/nasal Magill, High Volume, Low Pressure Cuff, REF 112080050 Open, Classified	BTR	None listed
Jun 29, 2023	TELEFLEX LLC Endotracheal Tube oral/nasal Magill, High Volume, Low Pressure Cuff, REF 112080055 Open, Classified	BTR	None listed
Jun 29, 2023	TELEFLEX LLC Endotracheal Tube oral/nasal Magill, High Volume, Low Pressure Cuff, REF 112080060 Open, Classified	BTR	None listed
Jun 29, 2023	TELEFLEX LLC Endotracheal Tube oral/nasal Magill, High Volume, Low Pressure Cuff, REF 112080065 Open, Classified	BTR	None listed
Jun 29, 2023	TELEFLEX LLC Endotracheal Tube oral/nasal Magill, High Volume, Low Pressure Cuff, REF 112080070 Open, Classified	BTR	None listed
Jun 29, 2023	TELEFLEX LLC Endotracheal Tube oral/nasal Magill, High Volume, Low Pressure Cuff, REF 112080075 Open, Classified	BTR	None listed
Jun 29, 2023	TELEFLEX LLC Endotracheal Tube oral/nasal Magill, High Volume, Low Pressure Cuff, REF 112080080 Open, Classified	BTR	None listed
Jun 29, 2023	TELEFLEX LLC Endotracheal Tube oral/nasal Magill, High Volume, Low Pressure Cuff, REF 112080085 Open, Classified	BTR	None listed
Jun 29, 2023	TELEFLEX LLC Endotracheal Tube oral/nasal Magill, High Volume, Low Pressure Cuff, REF 112080090 Open, Classified	BTR	None listed
Jun 29, 2023	TELEFLEX LLC Endotracheal Tube oral/nasal Magill, High Volume, Low Pressure Cuff, REF 112080095 Open, Classified	BTR	None listed
Jun 29, 2023	TELEFLEX LLC Endotracheal Tube oral/nasal Magill, High Volume, Low Pressure Cuff, REF 112080100 Open, Classified	BTR	None listed
Jun 29, 2023	TELEFLEX LLC Endotracheal Tube oral/nasal Murphy Eye, High Volume, Low Pressure Cuff, REF 112082050 Open, Classified	BTR	None listed
Jun 29, 2023	TELEFLEX LLC Endotracheal Tube oral/nasal Murphy Eye, High Volume, Low Pressure Cuff, REF 112082055 Open, Classified	BTR	None listed
Jun 29, 2023	TELEFLEX LLC Endotracheal Tube oral/nasal Murphy Eye, High Volume, Low Pressure Cuff, REF 112082060 Open, Classified	BTR	None listed
Jun 29, 2023	TELEFLEX LLC Endotracheal Tube oral/nasal Murphy Eye, High Volume, Low Pressure Cuff, REF 112082065 Open, Classified	BTR	None listed
Jun 29, 2023	TELEFLEX LLC Endotracheal Tube oral/nasal Murphy Eye, High Volume, Low Pressure Cuff, REF 112082070 Open, Classified	BTR	None listed
Jun 29, 2023	TELEFLEX LLC Endotracheal Tube oral/nasal Murphy Eye, High Volume, Low Pressure Cuff, REF 112082075 Open, Classified	BTR	None listed
Jun 29, 2023	TELEFLEX LLC Endotracheal Tube oral/nasal Murphy Eye, High Volume, Low Pressure Cuff, REF 112082080 Open, Classified	BTR	None listed
Jun 29, 2023	TELEFLEX LLC Endotracheal Tube oral/nasal Murphy Eye, High Volume, Low Pressure Cuff, REF 112082085 Open, Classified	BTR	None listed
Jun 29, 2023	TELEFLEX LLC Endotracheal Tube oral/nasal Murphy Eye, High Volume, Low Pressure Cuff, REF 112082090 Open, Classified	BTR	None listed
Jun 29, 2023	TELEFLEX LLC Endotracheal Tube oral/nasal Murphy Eye, High Volume, Low Pressure Cuff, REF 112082095 Open, Classified	BTR	None listed
Jun 29, 2023	TELEFLEX LLC Endotracheal Tube oral/nasal Murphy Eye, High Volume, Low Pressure Cuff, REF 112082100 Open, Classified	BTR	None listed
Jun 29, 2023	TELEFLEX LLC RUSCHELIT Safety Clear Tracheal Tube, oral/nasal, Magill, REF 112480045 Open, Classified	BTR	None listed
Jan 23, 2023	TELEFLEX LLC Endotracheal Tube labeled as the following: a. Flexi-Set Cuffed Endotracheal Tube and Stylet Set, oral/nasal; b. Endotracheal Tube oral/nasal Murphy Eye, High Volume, Low Pressure Cuff; c. RUSC Open, Classified	BTR	None listed
Jul 16, 2021	Teleflex Medical Europe Ltd RUSCH Flexi-Set Cuffed Endotracheal Tube and Stylet Set, oral/nasal, REF numbers: a) 504550 b) 504555 c) 504560 d) 504565 e) 504570 f) 504575 g) 504580 f) 504585 g) 504590 Terminated	BTR	None listed
Jul 16, 2021	Teleflex Medical Europe Ltd RUSCH Endotracheal Tube oral/nasal Magill, High Volume, Low Pressure Cuff, REF numbers: a) 112080050 b) 112080055 c) 112080060 d) 112080065 e) 112080070 f) 112080075 g) 112080080 h) 112080085 i) Terminated	BTR	None listed
Jul 16, 2021	Teleflex Medical Europe Ltd RUSCH Endotracheal Tube oral/nasal Murphy Eye, High Volume, Low Pressure Cuff, REF numbers: a) 112082050 b) 112082055 c) 112082060 d) 112082065 e) 112082070 f) 112082075 g) 112082080 h) 112082085 Terminated	BTR	None listed

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