The following data is part of a premarket notification filed by Atrium Medical Corp. with the FDA for Atrium Medical Corporation Icast Covered Stent.
| Device ID | K041269 |
| 510k Number | K041269 |
| Device Name: | ATRIUM MEDICAL CORPORATION ICAST COVERED STENT |
| Classification | Prosthesis, Tracheal, Expandable |
| Applicant | ATRIUM MEDICAL CORP. 5 WENTWORTH DR. Hudson, NH 03051 |
| Contact | Joseph P De Paolo |
| Correspondent | Joseph P De Paolo ATRIUM MEDICAL CORP. 5 WENTWORTH DR. Hudson, NH 03051 |
| Product Code | JCT |
| CFR Regulation Number | 878.3720 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-05-12 |
| Decision Date | 2004-09-14 |