# K982614: Rusch Polyflex Stent Kit

- Pathway: 510(k) (Traditional)
- Applicant: Rusch Intl.
- Decided: Dec 4, 1998 after 130 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.
No later device cites it as a predicate yet.
0 of 1 device 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) 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

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

Source page: https://510kreport.com/device/K982614
Methodology: https://510kreport.com/methodology