# K031641: Vascular Architects Aspire Covered Stent and 718 Delivery System

- Pathway: 510(k) (Traditional)
- Applicant: Vascular Architects, Inc.
- Decided: Aug 1, 2003 after 66 days
- Product code: JCT (Prosthesis, Tracheal, Expandable)
- 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
Longest line of descent: 3 generations back to K003173 (2001). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K003173: Aspire Covered Stent and Delivery Catheter, Vascular Architects, Inc. (2001) Summary page 4.
- K012544: Vascular Architects Aspire Covered Stent and Controlled Expansion Delivery System, Vascular Architects, Inc. (2001) Summary page 3.
- K030567: Modification to Vascular Architects Aspire Covered Stent and Contrilled Expansion Delivery System, Vascular Architects, Inc. (2003) Summary page 3.

## Indications for use
The Vascular Architects aSpire® Covered Stent and 718™ Delivery System are indicated for use in the treatment of tracheobronhial strictures produced by malignant neoplasms.

Source page: https://510kreport.com/device/K031641
Methodology: https://510kreport.com/methodology