INTRACOIL STENT
Device Facts
| Record ID | K001257 |
|---|---|
| Device Name | INTRACOIL STENT |
| Applicant | Intratherapeutics, Inc. |
| Product Code | JCT · General, Plastic Surgery |
| Decision Date | May 18, 2000 |
| Decision | SESE |
| Submission Type | Special |
| Regulation | 21 CFR 878.3720 |
| Device Class | Class 2 |
Regulatory Classification
Identification
The tracheal prosthesis is a rigid, flexible, or expandable tubular device made of a silicone, metal, or polymeric material that is intended to be implanted to restore the structure and/or function of the trachea or trachealbronchial tree. It may be unbranched or contain one or two branches. The metal tracheal prosthesis may be uncovered or covered with a polymeric material. This device may also include a device delivery system.
Special Controls
The special control for this device is FDA's “Guidance for the Content of Premarket Notification Submissions for Esophageal and Tracheal Prostheses.”
