# K080332: Polyflex Stent System with Delivery System, Model M00514270, M00514280, 00514290, 00514300, 00514310, 00514320, 00514330

- Pathway: 510(k) (Traditional)
- Applicant: Boston Scientific Corporation
- Decided: Sep 5, 2008 after 211 days
- Product code: ESW (Prosthesis, Esophageal)
- Device class: 2
- Regulation: 21 CFR 878.3610
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K030559 (2003). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K030559: Rusch Polyflex Stent for the Esophagus W/Introducer/Delivery System, Rusch Intl. (2003) Summary page 1.

## Indications for use
Stenting: Esophageal stenoses (strictures), such as stenting refractory benign strictures and/or malignant strictures (resectable and non-resectable) Stenting esophago-respiratory fistulas Maintaining esophagus lumen patency in esophageal strictures caused by intrinsic or extrinsic tumors

Source page: https://510kreport.com/device/K080332
Methodology: https://510kreport.com/methodology