The following data is part of a premarket notification filed by Sulzer Medica with the FDA for Sulzer Vascutek Eptfe Vascular Prosthesis.
| Device ID | K992832 |
| 510k Number | K992832 |
| Device Name: | SULZER VASCUTEK EPTFE VASCULAR PROSTHESIS |
| Classification | Prosthesis, Vascular Graft, Of 6mm And Greater Diameter |
| Applicant | SULZER MEDICA 1300 EAST ANDERSON LN. Austin, TX 78752 -1793 |
| Contact | Edward E Newton |
| Correspondent | Edward E Newton SULZER MEDICA 1300 EAST ANDERSON LN. Austin, TX 78752 -1793 |
| Product Code | DSY |
| CFR Regulation Number | 870.3450 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-08-23 |
| Decision Date | 1999-11-19 |
| Summary: | summary |