The following data is part of a premarket notification filed by Vascutek Ltd. with the FDA for Vascutek Twillweave Vascular Graft.
| Device ID | K964959 |
| 510k Number | K964959 |
| Device Name: | VASCUTEK TWILLWEAVE VASCULAR GRAFT |
| Classification | Prosthesis, Vascular Graft, Of 6mm And Greater Diameter |
| Applicant | VASCUTEK LTD. 1300 EAST ANDERSON LN. Austin, TX 78752 |
| Contact | Teena M Augostino |
| Correspondent | Teena M Augostino VASCUTEK LTD. 1300 EAST ANDERSON LN. Austin, TX 78752 |
| 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 | 1996-12-11 |
| Decision Date | 1997-03-10 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05037881126159 | K964959 | 000 |
| 05037881125282 | K964959 | 000 |
| 05037881125275 | K964959 | 000 |
| 05037881125213 | K964959 | 000 |
| 05037881125206 | K964959 | 000 |
| 05037881125190 | K964959 | 000 |
| 05037881125183 | K964959 | 000 |
| 05037881125060 | K964959 | 000 |
| 05037881125053 | K964959 | 000 |
| 05037881125046 | K964959 | 000 |
| 05037881125039 | K964959 | 000 |
| 05037881125022 | K964959 | 000 |
| 05037881125442 | K964959 | 000 |
| 05037881125459 | K964959 | 000 |
| 05037881125565 | K964959 | 000 |
| 05037881126111 | K964959 | 000 |
| 05037881125718 | K964959 | 000 |
| 05037881125701 | K964959 | 000 |
| 05037881125695 | K964959 | 000 |
| 05037881125688 | K964959 | 000 |
| 05037881125671 | K964959 | 000 |
| 05037881125664 | K964959 | 000 |
| 05037881125657 | K964959 | 000 |
| 05037881125596 | K964959 | 000 |
| 05037881125589 | K964959 | 000 |
| 05037881125572 | K964959 | 000 |
| 05037881125015 | K964959 | 000 |