NYT — Prosthesis, Tracheal, Expandable, Polymeric Class II

FDA Device Classification

Classification Details

Product Code
NYT
Device Class
Class II
Regulation Number
878.3720
Submission Type
Review Panel
SU
Medical Specialty
General, Plastic Surgery
Implant
Yes

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 exhausted.

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K013266rusch intlRUSCH POLYFLEX STENT KITNovember 27, 2001
K982614rusch intlRUSCH POLYFLEX STENT KITDecember 4, 1998
K953593ruschRUSCH TRACHEAL BRONCHIAL Y STENTOctober 13, 1995