The following data is part of a premarket notification filed by Atrium Medical Corp. with the FDA for Advanta Graft (.
| Device ID | K992958 |
| 510k Number | K992958 |
| Device Name: | ADVANTA GRAFT ( |
| Classification | Prosthesis, Vascular Graft, Of Less Then 6mm Diameter |
| Applicant | ATRIUM MEDICAL CORP. 5 WENTWORTH DR. Hudson, NH 03051 |
| Contact | Karen Hall |
| Correspondent | Karen Hall ATRIUM MEDICAL CORP. 5 WENTWORTH DR. Hudson, NH 03051 |
| Product Code | DYF |
| CFR Regulation Number | 870.3450 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-09-02 |
| Decision Date | 1999-10-01 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00650862212792 | K992958 | 000 |
| 00650862212778 | K992958 | 000 |
| 00650862212761 | K992958 | 000 |
| 00650862210743 | K992958 | 000 |
| 00650862210248 | K992958 | 000 |
| 00650862210156 | K992958 | 000 |