K041269 is an FDA 510(k) clearance for the ATRIUM MEDICAL CORPORATION ICAST COVERED STENT. This device is classified as a Prosthesis, Tracheal, Expandable (Class II - Special Controls, product code JCT).
Submitted by Atrium Medical Corp. (Hudson, US). The FDA issued a Cleared decision on September 14, 2004, 125 days after receiving the submission on May 12, 2004.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.3720.
| 510(k) Number | K041269 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 12, 2004 |
| Decision Date | September 14, 2004 |
| Days to Decision | 125 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Statement |
| Product Code | JCT — Prosthesis, Tracheal, Expandable |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 878.3720 |