The following data is part of a premarket notification filed by Atrium Medical Corp. with the FDA for Atrium Plasma Tfe Synthetic Artery.
| Device ID | K853725 |
| 510k Number | K853725 |
| Device Name: | ATRIUM PLASMA TFE SYNTHETIC ARTERY |
| Classification | Prosthesis, Vascular Graft, Of 6mm And Greater Diameter |
| Applicant | ATRIUM MEDICAL CORP. 17 CLINTON DR. Hollis, NH 03049 |
| Contact | Steve Herweck |
| Correspondent | Steve Herweck ATRIUM MEDICAL CORP. 17 CLINTON DR. Hollis, NH 03049 |
| Product Code | DSY |
| CFR Regulation Number | 870.3450 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-09-06 |
| Decision Date | 1985-12-09 |