The following data is part of a premarket notification filed by Carbomedics, Inc. with the FDA for Vascutek Vascusoft Plus Vascular Graft.
| Device ID | K960706 |
| 510k Number | K960706 |
| Device Name: | VASCUTEK VASCUSOFT PLUS VASCULAR GRAFT |
| Classification | Prosthesis, Vascular Graft, Of 6mm And Greater Diameter |
| Applicant | CARBOMEDICS, INC. 1300 EAST ANDERSON LN. Austin, TX 78752 -1793 |
| Contact | Teena M Augostino |
| Correspondent | Teena M Augostino CARBOMEDICS, INC. 1300 EAST ANDERSON LN. Austin, TX 78752 -1793 |
| Product Code | DSY |
| CFR Regulation Number | 870.3450 [🔎] |
| Decision | Se - Postmarket Surveillance Required (SESP) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-02-21 |
| Decision Date | 1996-04-25 |
| Summary: | summary |