# K050814: Atrium Icast Covered Stent

- Pathway: 510(k) (Special)
- Applicant: Atrium Medical Corp.
- Decided: May 6, 2005 after 36 days
- Product code: JCT (Prosthesis, Tracheal, Expandable)
- Device class: 2
- Regulation: 21 CFR 878.3720
- Recalls of this device: 2 (1 Class I)
- 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.
1 of 1 device in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Recalls of this device
- Mar 3, 2022 · Class I · Z-1077-2022: Firm has observed increased rate of customer complaints related to separation of the balloon or catheter hub from the delivery catheter during delivery system withdrawal causing procedural delay and p
- May 25, 2017 · Class II · Z-2761-2017: Firm received a complaint that a customer who ordered an ADVANTA V12 7mm x 22mm x 120cm received an ADVANTA v12 7 mm x 38 mm x 80 cm, due to the manifold (catheter hub) was printed as 7mm x 38 mm x 80

## Indications for use
The iCAST Covered Stent is indicated for the treatment of tracheobronchial strictures produced by malignant neoplasms.

Source page: https://510kreport.com/device/K050814
Methodology: https://510kreport.com/methodology