510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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NYTClass II

Prosthesis, Tracheal, Expandable, Polymeric

21 CFR 878.3720 / General, Plastic Surgery
FDA source (opens on fda.gov)

NYT is the FDA product code for Prosthesis, Tracheal, Expandable, Polymeric, a class II device type, regulated under 21 CFR 878.3720. FDA's definition for this code reads: "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". As of , FDA records hold 3 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
NYT
Device name
Prosthesis, Tracheal, Expandable, Polymeric
FDA 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.
Regulation
21 CFR 878.3720
Device class
Class II
Review panel
General, Plastic Surgery
Submission type
510(k)
Implant
Yes
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
3
Ingested recalls
0

Clearances, product code NYT

By decision year
3 clearances under product code NYT with a decision year between 1995 and 2001, 1995 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code NYT by decision year
YearClearances
19951
19981
20011

Applicants with the most clearances

Product code NYT
Applicants holding the most 510(k) clearances under product code NYT
ApplicantClearances
Rusch Intl.2
Rusch, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code