510(k) K822082 ยท BTR Tube, Tracheal (W/Wo Connector)
SHERIDAN/HVT,CF, UNCUFFED
| Applicant | Sheridan Catheter Corp., Mchenry IL, US |
| Decision | Substantially Equivalent, Aug 10, 1982 |
| Received | Jul 12, 1982 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K822082
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 9, 2019 | Teleflex 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 |
BTR | None listed |
| Sep 9, 2019 | Teleflex 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 |
BTR | None listed |
| Sep 9, 2019 | Teleflex 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 |
BTR | None listed |
| Sep 9, 2019 | Teleflex 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 |
BTR | None listed |
| Sep 9, 2019 | Teleflex 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 |
BTR | None listed |
| Sep 9, 2019 | Teleflex 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 |
BTR | None listed |
| Sep 9, 2019 | Teleflex Medical Sheridan/CF Novaplus 7.0 mm, REF V5-10114
Product Usage:
Tracheal tube/airway management Terminated |
BTR | None listed |
| Sep 9, 2019 | Teleflex 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 |
BTR | None listed |
| Jul 30, 2019 | Centurion Medical Products Corporation Sheridan Endotracheal Tube contained inside Centurion kit code TC7855. Terminated |
BTR | None listed |
| Jun 19, 2019 | Teleflex Medical Hudson RCI Sheridan LTS, Product Code 5-11112
Product Usage:
Tracheal tube/airway management Terminated |
BTR | None listed |
| Jun 19, 2019 | Teleflex 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 |
BTR | None listed |
| Jun 19, 2019 | Teleflex 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 |
BTR | None listed |
| Jun 19, 2019 | Teleflex 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 |
BTR | None listed |
| Jun 19, 2019 | Teleflex 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 |
BTR | None listed |
| Jun 19, 2019 | Teleflex 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 |
BTR | None listed |
| Jun 19, 2019 | Teleflex Medical Sheridan/CF Novaplus 7.0 mm, Product Code V5-10114
Product Usage:
Tracheal tube/airway management Terminated |
BTR | None listed |
| Jun 19, 2019 | Teleflex 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 |
BTR | None listed |
| Feb 9, 2017 | Teleflex 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 |
BTR | None listed |
| Jun 9, 2016 | Teleflex 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 |
BTR | None listed |
| Feb 10, 2015 | Teleflex Medical Hudson RCI, Sheridan, Preformed Tracheal Tubes, Cuffed and Uncuffed, Rx Only, Sterile, Teleflex Medical. Terminated |
BTR | None listed |
| Dec 12, 2014 | Teleflex 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 |
BTR | None listed |
| Aug 26, 2009 | Teleflex 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 |
BTR | None listed |
| Aug 26, 2009 | Teleflex 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 |
BTR | None listed |
| Nov 2, 2006 | Teleflex 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 |
BTR | None listed |
| Nov 2, 2006 | Teleflex 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 |
BTR | None listed |
| Nov 2, 2006 | Teleflex 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 |
BTR | None listed |
| Mar 10, 2005 | Teleflex 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 |
BTR | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.