Atlas FDA

SHERIDAN/HVT,CF, UNCUFFED

FDA 510(k) clearance K822082 · decided 1982-08-10

Clearance details

K-number
K822082
Device name
SHERIDAN/HVT,CF, UNCUFFED
Applicant
Sheridan Catheter Corp.
Decision
Substantially Equivalent
Date received
1982-07-12
Decision date
1982-08-10
Days to decision
29 days
Clearance type
Traditional
Product code
BTR
Device class
2
Regulation number
868.5730
Medical specialty
Anesthesiology
Advisory committee
Anesthesiology
Location
Mchenry, IL, US
Third-party review
No
Expedited review
No

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Recalls involving this device

RecordFirmDate
Hudson RCI Sheridan LTS: a) 4.0 mm, REF 5-11108 b) 5.0 mm, REF 5-11110 c) 6.0 mm, REF 5-11 recall (Z-2311-2019)Teleflex Medical2019-09-09
Hudson RCI Sheridan/CF: a) 3.0 mm, REF 5-10106, REF 5-10206 b) 3.5 mm, REF 5-10107 c) 4.0 recall (Z-2312-2019)Teleflex Medical2019-09-09
Hudson RCI Sheridan EZ-ENDO: a) 5.0 mm, REF 5-22510 b) 5.5 mm, REF 5-22511 c) 7.0 mm, REF recall (Z-2313-2019)Teleflex Medical2019-09-09
Hudson RCI Sheridan Preformed: a) 3.0 mm, REF 5-22006, REF 5-22106 b) 3.5 mm, REF 5-22007, recall (Z-2314-2019)Teleflex Medical2019-09-09
Hudson RCI Sheridan Uncuffed: a) 2.0 mm, REF 5-10404 b) 2.5 mm, REF 5-10405 c) 3.0 mm, REF recall (Z-2315-2019)Teleflex Medical2019-09-09
Hudson RCI Sheridan/HVT: a) 5.0 mm, REF 5-10310 b) 5.5 mm, REF 5-10311 c) 6.0 mm, REF 5-10 recall (Z-2316-2019)Teleflex Medical2019-09-09
Sheridan/CF Novaplus 7.0 mm, REF V5-10114 Product Usage: Tracheal tube/airway management recall (Z-2317-2019)Teleflex Medical2019-09-09
Sheridan/HVT Novaplus: a) 7.0 mm, REF V5-10314 b) 7.5 mm, REF V5-10315 c) 8.0 mm, REF V5-1 recall (Z-2318-2019)Teleflex Medical2019-09-09
Sheridan Endotracheal Tube contained inside Centurion kit code TC7855. recall (Z-1956-2019)Centurion Medical Products Corporation2019-07-30
Hudson RCI Sheridan LTS, Product Code 5-11112 Product Usage: Tracheal tube/airway manageme recall (Z-1759-2019)Teleflex Medical2019-06-19
Hudson RCI Sheridan: 1) CF 6.0 mm, Product Codes: 5-10112, 5-10212 2) CF 6.5 mm, Product C recall (Z-1760-2019)Teleflex Medical2019-06-19
Hudson RCI Sheridan: 1) EZ-ENDO 6.0 mm, Product Code 5-22512 2) EZ-ENDO 6.5 mm, Product Co recall (Z-1761-2019)Teleflex Medical2019-06-19
Hudson RCI Sheridan: 1) Preformed 6.0 mm, Product Codes: a) 5-22212, b) 5-22312, c) 5-2211 recall (Z-1762-2019)Teleflex Medical2019-06-19
Hudson RCI Sheridan: 1) Uncuffed 6.0 mm, Product Code 5-10412 2) Uncuffed 6.5 mm, Product recall (Z-1763-2019)Teleflex Medical2019-06-19
Hudson RCI Sheridan: 1) HVT 6.0 mm, Product Code 5-10312 2) HVT 6.5 mm, Product Code 5-103 recall (Z-1764-2019)Teleflex Medical2019-06-19
Sheridan/CF Novaplus 7.0 mm, Product Code V5-10114 Product Usage: Tracheal tube/airway man recall (Z-1765-2019)Teleflex Medical2019-06-19
Sheridan/HVT: 1) Novaplus 7.0 mm, Product Code V5-10314 2) Novaplus 7.5 mm, Product Code V recall (Z-1766-2019)Teleflex Medical2019-06-19
Sheridan/CF, Cuffed Tracheal Tube, Catalog # 5-10114 and Sheridan/HVT Cuffed Tracheal Tube recall (Z-1177-2017)Teleflex Medical2017-02-09
Sterile Sheridan/HVT Cuffed, Murphy Eye, Tracheal Tube, Ref: V5-10314, ID: 7.0 mm, Rx Only recall (Z-1938-2016)Teleflex Medical2016-06-09
Hudson RCI, Sheridan, Preformed Tracheal Tubes, Cuffed and Uncuffed, Rx Only, Sterile, Tel recall (Z-1078-2015)Teleflex Medical2015-02-10
Sheridan/CF Cuffed Tracheal Tube, Sterile, Rx only, Teleflex Medical, Research Triangle Pa recall (Z-0799-2015)Teleflex Medical2014-12-12
Sheridan Preformed Cuffed Tracheal Tube, Nasal 6.5, Catalog Number: 5-22313, Teleflex Medi recall (Z-1890-2009)Teleflex Medical2009-08-26
Sheridan Preformed Cuffed Tracheal Tube, Nasal 7.0, Catalog Number: 5-22314, Teleflex Medi recall (Z-1891-2009)Teleflex Medical2009-08-26
Sheridan Preformed Uncuffed Oral Tracheal Tube, 3.0 mm; a Rx, sterile, single use tracheal recall (Z-0126-2007)Teleflex Medical2006-11-02
Sheridan Preformed Cuffed Oral Tracheal Tube, 5.0 mm; a Rx, sterile, single use tracheal t recall (Z-0127-2007)Teleflex Medical2006-11-02
Sheridan Preformed Cuffed Nasal Tracheal Tube, 7.5 mm; a Rx, sterile, single use tracheal recall (Z-0128-2007)Teleflex Medical2006-11-02
Novaplus Sheridan/HVT Cuffed, Murphy Eye Tracheal Tube; an Rx, ETO sterilized, single use recall (Z-0582-05)Teleflex Medical2005-03-10