Prosthesis, Tracheal, Expandable, Polymeric

Device Code: 5792

Product Code(s): NYT

Definition: The Device Is Intended To Provide Support To Weakened Or Constricting Airway Walls And Indicated For The Treatment Of Tracheobronchial Strictures Produced By Malignant Neoplasms Or In Benign Strictures, After All Alternative Therapies Have Been Exhau

Device Classification Information

Device Type ID5792
Device NameProsthesis, Tracheal, Expandable, Polymeric
Physical StateThe Device Is A Self-expanding Tubular Device, Traditionally Made Of Silicone. Devices Can Range Roughly From 6-14mm In Diameter And Have Lengths As Small As 20 Mm To Lengths As Long As 150mm.
Technical MethodThe Device Functions Independently Providing Physical Support To The Constricting Airway.
Target AreaThe Target Area Is The Tracheobronchial Tree.
Regulation DescriptionTracheal Prosthesis.
Regulation Medical SpecialtyGeneral & Plastic Surgery
Review PanelGeneral & Plastic Surgery
Premarket Review Office Of Device Evaluation (ODE)
Division Of Surgical Devices (DSD)
General Surgery Devices Branch One - Light Based/Laser (GSDB1)
Submission Type510(k)
CFR Regulation Number878.3720 [🔎]
FDA Device ClassificationClass 2 Medical Device
Product CodeNYT
GMP ExemptNo
Summary MREligible
Implanted DeviceYes
Life Support DeviceNo
Third Party Review Not Third Party Eligible

Recognized Standards

Total Product Life Cycle

Device Type ID5792
DeviceProsthesis, Tracheal, Expandable, Polymeric
Product CodeNYT
FDA Device ClassificationClass 2 Medical Device
Regulation DescriptionTracheal Prosthesis.
CFR Regulation Number878.3720 [🔎]
Device Problems
Adverse Event Without Identified Device Or Use Problem
3
Stent
3
Material Deformation
2
Cover
1
Partial Blockage
1
Material Integrity Problem
1
Total Device Problems 11
TPLC Last Update: 2019-04-02 21:12:32

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