The following data is part of a premarket notification filed by Atrium Medical Corp. with the FDA for Atrium Icast Covered Stent.
| Device ID | K050814 |
| 510k Number | K050814 |
| Device Name: | ATRIUM ICAST COVERED STENT |
| Classification | Prosthesis, Tracheal, Expandable |
| Applicant | ATRIUM MEDICAL CORP. 5 WENTWORTH DR. Hudson, NH 03051 |
| Contact | Joseph P Paolo |
| Correspondent | Joseph P Paolo ATRIUM MEDICAL CORP. 5 WENTWORTH DR. Hudson, NH 03051 |
| Product Code | JCT |
| CFR Regulation Number | 878.3720 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-03-31 |
| Decision Date | 2005-05-06 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00650862854558 | K050814 | 000 |
| 00650862854152 | K050814 | 000 |
| 00650862854145 | K050814 | 000 |
| 00650862854138 | K050814 | 000 |
| 00650862854121 | K050814 | 000 |
| 00650862854114 | K050814 | 000 |
| 00650862854107 | K050814 | 000 |
| 00650862854091 | K050814 | 000 |
| 00650862854084 | K050814 | 000 |
| 00650862854077 | K050814 | 000 |
| 00650862854060 | K050814 | 000 |
| 00650862854053 | K050814 | 000 |
| 00650862854046 | K050814 | 000 |
| 00650862854039 | K050814 | 000 |
| 00650862854022 | K050814 | 000 |
| 00650862854015 | K050814 | 000 |
| 00650862854169 | K050814 | 000 |
| 00650862854176 | K050814 | 000 |
| 00650862854541 | K050814 | 000 |
| 00650862854534 | K050814 | 000 |
| 00650862854527 | K050814 | 000 |
| 00650862854510 | K050814 | 000 |
| 00650862854503 | K050814 | 000 |
| 00650862854459 | K050814 | 000 |
| 00650862854442 | K050814 | 000 |
| 00650862854435 | K050814 | 000 |
| 00650862854428 | K050814 | 000 |
| 00650862854411 | K050814 | 000 |
| 00650862854404 | K050814 | 000 |
| 00650862854244 | K050814 | 000 |
| 00650862854206 | K050814 | 000 |
| 00650862854190 | K050814 | 000 |
| 00650862854183 | K050814 | 000 |
| 00650862854008 | K050814 | 000 |