NYT · Class II · 21 CFR 878.3720

FDA Product Code NYT: Prosthesis, Tracheal, Expandable, Polymeric

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.

Leading manufacturers include Rusch Intl..

3
Total
3
Cleared
87d
Avg days
1995
Since

FDA 510(k) Cleared Prosthesis, Tracheal, Expandable, Polymeric Devices (Product Code NYT)

3 devices
1–3 of 3
Cleared Nov 27, 2001
RUSCH POLYFLEX STENT KIT
K013266
Rusch Intl.
General & Plastic Surgery · 57d
Cleared Dec 04, 1998
RUSCH POLYFLEX STENT KIT
K982614
Rusch Intl.
General & Plastic Surgery · 130d

About Product Code NYT - Regulatory Context