The following data is part of a premarket notification filed by Atrium Medical Corp. with the FDA for Atrium Graduated Wall Flixene Ax-bifem Graft.
| Device ID | K102596 |
| 510k Number | K102596 |
| Device Name: | ATRIUM GRADUATED WALL FLIXENE AX-BIFEM GRAFT |
| Classification | Prosthesis, Vascular Graft, Of 6mm And Greater Diameter |
| Applicant | ATRIUM MEDICAL CORP. 5 WENTWORTH DR. Hudson, NH 03051 |
| Contact | Raymond J Kelly |
| Correspondent | Raymond J Kelly 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 | 2010-09-09 |
| Decision Date | 2010-10-05 |