Product code NYT— General, Plastic Surgery

RUSCH POLYFLEX STENT KIT

Classification name: Prosthesis, Tracheal, Expandable, Polymeric
Device class: Class 2
Regulation: 21 CFR 878.3720
Advisory panel: General, Plastic Surgery
Total cleared: 3
First cleared: 1995-10-13
Most recent: 2001-11-27

FDA classification 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.”
— U.S. Food and Drug Administration, device classification record for product code NYT under 21 CFR 878.3720, via openFDA

Market context for product code NYT

FDA has cleared 3 devices under product code NYT between 1995 and 2001, filed by 2 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Clearances per year

20011 clearance
19981 clearance
19951 clearance

Top applicants under product code NYT

Rusch Intl.2 clearances
Rusch, Inc.1 clearance

Recent clearances under product code NYT

K013266 — RUSCH POLYFLEX STENT KITRusch Intl.·2001-11-27
K982614 — RUSCH POLYFLEX STENT KITRusch Intl.·1998-12-04
K953593 — RUSCH TRACHEAL BRONCHIAL Y STENTRusch, Inc.·1995-10-13

Data sourced from openFDA. This site is unofficial and independent of the FDA.