ClearanceBrief
510(k) K822082 ยท BTR Tube, Tracheal (W/Wo Connector)

SHERIDAN/HVT,CF, UNCUFFED

ApplicantSheridan Catheter Corp., Mchenry IL, US
DecisionSubstantially Equivalent, Aug 10, 1982
ReceivedJul 12, 1982
TypeTraditional
FDA recordOpen on fda.gov

Recalls that name K822082

DateFirm and productCodeLinked 510(k)
Sep 9, 2019Teleflex Medical
Hudson RCI Sheridan LTS: a) 4.0 mm, REF 5-11108 b) 5.0 mm, REF 5-11110 c) 6.0 mm, REF 5-11112 Product Usage: Tracheal tube/airway management
Terminated
BTRNone listed
Sep 9, 2019Teleflex Medical
Hudson RCI Sheridan/CF: a) 3.0 mm, REF 5-10106, REF 5-10206 b) 3.5 mm, REF 5-10107 c) 4.0 mm, REF 5-10108, REF 5-10208 d) 4.5 mm, REF 5-10109 e) 5.0 mm, REF 5-10110, REF 5-10210 f) 5.5 mm, REF 5-1011
Terminated
BTRNone listed
Sep 9, 2019Teleflex Medical
Hudson RCI Sheridan EZ-ENDO: a) 5.0 mm, REF 5-22510 b) 5.5 mm, REF 5-22511 c) 7.0 mm, REF 5-22514 d) 7.5 mm, REF 5-22515 e) 8.0 mm, REF 5-22516 f) 8.5 mm, REF 5-22517 g) 9.0 mm, REF 5-22518 h) 6.0 mm,
Terminated
BTRNone listed
Sep 9, 2019Teleflex Medical
Hudson RCI Sheridan Preformed: a) 3.0 mm, REF 5-22006, REF 5-22106 b) 3.5 mm, REF 5-22007, REF 5-22107 c) 4.0 mm, REF 5-22008, REF 5-22108, REF 5-22208 d) 4.5 mm, REF 5-22009, REF 5-22109, REF 5-22209
Terminated
BTRNone listed
Sep 9, 2019Teleflex Medical
Hudson RCI Sheridan Uncuffed: a) 2.0 mm, REF 5-10404 b) 2.5 mm, REF 5-10405 c) 3.0 mm, REF 5-10406 d) 3.5 mm, REF 5-10407 e) 4.0 mm, REF 5-10408 f) 4.5 mm, REF 5-10409 g) 5.0 mm, REF 5-10410 h) 5.5
Terminated
BTRNone listed
Sep 9, 2019Teleflex Medical
Hudson RCI Sheridan/HVT: a) 5.0 mm, REF 5-10310 b) 5.5 mm, REF 5-10311 c) 6.0 mm, REF 5-10312 d) 6.5 mm, REF 5-10313 e) 7.0 mm, REF 5-10314 f) 7.5 mm, REF 5-10315 g) 8.0 mm, REF 5-10316 h) 8.5 mm, REF
Terminated
BTRNone listed
Sep 9, 2019Teleflex Medical
Sheridan/CF Novaplus 7.0 mm, REF V5-10114 Product Usage: Tracheal tube/airway management
Terminated
BTRNone listed
Sep 9, 2019Teleflex Medical
Sheridan/HVT Novaplus: a) 7.0 mm, REF V5-10314 b) 7.5 mm, REF V5-10315 c) 8.0 mm, REF V5-10316 d) 8.5 mm, REF V5-10317 Product Usage: Tracheal tube/airway management
Terminated
BTRNone listed
Jul 30, 2019Centurion Medical Products Corporation
Sheridan Endotracheal Tube contained inside Centurion kit code TC7855.
Terminated
BTRNone listed
Jun 19, 2019Teleflex Medical
Hudson RCI Sheridan LTS, Product Code 5-11112 Product Usage: Tracheal tube/airway management
Terminated
BTRNone listed
Jun 19, 2019Teleflex Medical
Hudson RCI Sheridan: 1) CF 6.0 mm, Product Codes: 5-10112, 5-10212 2) CF 6.5 mm, Product Codes: 5-10113, 5-10213 3) CF 7.0 mm, Product Codes: 5-10114, 5-10214 4) CF 7.5 mm, Product Codes: V5-10115
Terminated
BTRNone listed
Jun 19, 2019Teleflex Medical
Hudson RCI Sheridan: 1) EZ-ENDO 6.0 mm, Product Code 5-22512 2) EZ-ENDO 6.5 mm, Product Code 5-22513 3) EZ-ENDO 7.0 mm, Product Code 5-22514 4) EZ-ENDO 7.5 mm, Product Code 5-22515 5) EZ-ENDO 8.0 mm,
Terminated
BTRNone listed
Jun 19, 2019Teleflex Medical
Hudson RCI Sheridan: 1) Preformed 6.0 mm, Product Codes: a) 5-22212, b) 5-22312, c) 5-22112, d) 5-22012, 2) Preformed 6.5 mm, Product Codes: a) 5-22313, b) 5-22213, c) 5-22013, d) 5-22113,
Terminated
BTRNone listed
Jun 19, 2019Teleflex Medical
Hudson RCI Sheridan: 1) Uncuffed 6.0 mm, Product Code 5-10412 2) Uncuffed 6.5 mm, Product Code 5-10413 3) Uncuffed 7.0 mm, Product Code 5-10414 Product Usage: Tracheal tube/airway management
Terminated
BTRNone listed
Jun 19, 2019Teleflex Medical
Hudson RCI Sheridan: 1) HVT 6.0 mm, Product Code 5-10312 2) HVT 6.5 mm, Product Code 5-10313 3) HVT 7.0 mm, Product Code 5-10314 4) HVT 7.5 mm, Product Code 5-10315 5) HVT 8.0 mm, Product Code 5-10316
Terminated
BTRNone listed
Jun 19, 2019Teleflex Medical
Sheridan/CF Novaplus 7.0 mm, Product Code V5-10114 Product Usage: Tracheal tube/airway management
Terminated
BTRNone listed
Jun 19, 2019Teleflex Medical
Sheridan/HVT: 1) Novaplus 7.0 mm, Product Code V5-10314 2) Novaplus 7.5 mm, Product Code V5-10315 3) Novaplus 8.0 mm, Product Code V5-10316 4) Novaplus 8.5 mm, Product Code V5-10317 Product Usage: Tr
Terminated
BTRNone listed
Feb 9, 2017Teleflex Medical
Sheridan/CF, Cuffed Tracheal Tube, Catalog # 5-10114 and Sheridan/HVT Cuffed Tracheal Tube, Catalog # 5-10315 A tracheal tube is inserted into a patients mouth or nose for airway management
Terminated
BTRNone listed
Jun 9, 2016Teleflex Medical
Sterile Sheridan/HVT Cuffed, Murphy Eye, Tracheal Tube, Ref: V5-10314, ID: 7.0 mm, Rx Only, Manufactured by: Teleflex Incorporated. A tracheal tube is inserted into a patients mouth or nose for airwa
Terminated
BTRNone listed
Feb 10, 2015Teleflex Medical
Hudson RCI, Sheridan, Preformed Tracheal Tubes, Cuffed and Uncuffed, Rx Only, Sterile, Teleflex Medical.
Terminated
BTRNone listed
Dec 12, 2014Teleflex Medical
Sheridan/CF Cuffed Tracheal Tube, Sterile, Rx only, Teleflex Medical, Research Triangle Park, NC 27708. Designed for oral and nasal intubation and are indicated for airway management.
Terminated
BTRNone listed
Aug 26, 2009Teleflex Medical
Sheridan Preformed Cuffed Tracheal Tube, Nasal 6.5, Catalog Number: 5-22313, Teleflex Medical Ltd, Research Triangle Park, NC 27709 Used for oral or nasal intubation for airway management.
Terminated
BTRNone listed
Aug 26, 2009Teleflex Medical
Sheridan Preformed Cuffed Tracheal Tube, Nasal 7.0, Catalog Number: 5-22314, Teleflex Medical Ltd, Research Triangle Park, NC 27709 Used for oral or nasal intubation for airway management.
Terminated
BTRNone listed
Nov 2, 2006Teleflex Medical
Sheridan Preformed Uncuffed Oral Tracheal Tube, 3.0 mm; a Rx, sterile, single use tracheal tube; Hudson Respiratory Care Inc., Temecula, CA 92589-9020, Manufactured in Mexico; catalog number (REF) 5-2
Terminated
BTRNone listed
Nov 2, 2006Teleflex Medical
Sheridan Preformed Cuffed Oral Tracheal Tube, 5.0 mm; a Rx, sterile, single use tracheal tube; Hudson Respiratory Care Inc., Temecula, CA 92589-9020, Manufactured in Mexico; catalog number (REF) 5-222
Terminated
BTRNone listed
Nov 2, 2006Teleflex Medical
Sheridan Preformed Cuffed Nasal Tracheal Tube, 7.5 mm; a Rx, sterile, single use tracheal tube; Hudson Respiratory Care Inc., Temecula, CA 92589-9020, Manufactured in Mexico; catalog number (REF) 5-22
Terminated
BTRNone listed
Mar 10, 2005Teleflex Medical
Novaplus Sheridan/HVT Cuffed, Murphy Eye Tracheal Tube; an Rx, ETO sterilized, single use device inserted into the patient's trachea via the mouth to maintain an open airway; Hudson RCI, Temecula, CA
Terminated
BTRNone listed

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