# K021563: Intracoil Self-Expanding Peripheral Stent

- Pathway: 510(k) (Special)
- Applicant: Sulzer Intratherapeutics, Inc.
- Decided: May 31, 2002 after 18 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: 7 generations back to K923119 (1992). 18 ancestors in all.
No later device cites it as a predicate yet.
0 of 19 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K990221: Intracoil Peripheral Stent, Intratherapeutics, Inc. (1999) Summary page 4.
- K001257: Intracoil Stent, Intratherapeutics, Inc. (2000) Summary page 4.

## Indications for use
The IntraCoil® Peripheral Stent is indicated for use in the treatment of bronchial strictures produced by malignant neoplasms.

Source page: https://510kreport.com/device/K021563
Methodology: https://510kreport.com/methodology