The following data is part of a premarket notification filed by Carbomedics, Inc. with the FDA for Vascutek Gelweave Vascular Graft (bifurcated Configuration).
| Device ID | K964665 |
| 510k Number | K964665 |
| Device Name: | VASCUTEK GELWEAVE VASCULAR GRAFT (BIFURCATED CONFIGURATION) |
| 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 Subject To Tracking Reg (ST) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-11-21 |
| Decision Date | 1997-02-19 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05037881020594 | K964665 | 000 |
| 05037881020587 | K964665 | 000 |
| 05037881013541 | K964665 | 000 |