The following data is part of a premarket notification filed by Atrium Medical Corp. with the FDA for Advanta Sst Graft (>_6mm).
| Device ID | K010516 |
| 510k Number | K010516 |
| Device Name: | ADVANTA SST GRAFT (>_6MM) |
| Classification | Prosthesis, Vascular Graft, Of 6mm And Greater 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 | DSY |
| CFR Regulation Number | 870.3450 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-02-22 |
| Decision Date | 2001-05-18 |