# K013266: Rusch Polyflex Stent Kit

- Pathway: 510(k) (Traditional)
- Applicant: Rusch Intl.
- Decided: Nov 27, 2001 after 57 days
- Product code: NYT (Prosthesis, Tracheal, Expandable, Polymeric)
- Device class: 2
- Regulation: 21 CFR 878.3720
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
16 later devices descend from it; 4 cite it directly.
0 of 17 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Boston Scientific Ultraflex: named in the summary without a submission number
- (no number) Schneider Wall Stent: named in the summary without a submission number
- (no number) Cook Gianturco-Wallace Tracheobronchial “Z” Stent: named in the summary without a submission number
- (no number) Bryan Dumon Tracheal Bronchial Stent: named in the summary without a submission number
- (no number) Hood Tracheal Bronchial Stent: named in the summary without a submission number
- (no number) Hood Westaby Stent: named in the summary without a submission number

## Most influential descendants
- K033053: Alveolus, TB-STS Tracheobronchial Stent System (2004), 15 descendants of its own
- K062511: Aero Tracheobronchial Stent System, Model 90129-2XX (2007), 14 descendants of its own
- K082284: Aero Tracheobronchial Stent Technology System (2008), 11 descendants of its own
- K083625: Aero DV Tracheobronchial Stent System (2009), 6 descendants of its own
- K121048: Ultraflex Tracheobronchial Stent System- Sterile Uncovered (2012), 5 descendants of its own

## Indications for use
Compression or strictures due to tumors (trachea and main bronchus) Stenosis of the central airways (such as trachea and main bronchus) Tracheo Esophageal fistula Airway complications such as-anastomosis and stenosis

Source page: https://510kreport.com/device/K013266
Methodology: https://510kreport.com/methodology