The following data is part of a premarket notification filed by Atrium Medical Corp. with the FDA for Atrium Flixene Ifg Vascular Graft.
| Device ID | K122138 |
| 510k Number | K122138 |
| Device Name: | ATRIUM FLIXENE IFG VASCULAR GRAFT |
| Classification | Prosthesis, Vascular Graft, Of 6mm And Greater Diameter |
| Applicant | ATRIUM MEDICAL CORP. 5 WENTWORTH DR Hudson, NH 03051 |
| Contact | Megan Mccagh |
| Correspondent | Megan Mccagh ATRIUM MEDICAL CORP. 5 WENTWORTH DR Hudson, NH 03051 |
| Product Code | DSY |
| CFR Regulation Number | 870.3450 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-07-19 |
| Decision Date | 2012-08-17 |