The following data is part of a premarket notification filed by Vascutek Ltd. with the FDA for Vascutek Gelweave Vascular Graft.
| Device ID | K952293 |
| 510k Number | K952293 |
| Device Name: | VASCUTEK GELWEAVE VASCULAR GRAFT |
| Classification | Prosthesis, Vascular Graft, Of 6mm And Greater Diameter |
| Applicant | VASCUTEK LTD. 1300-A EAST ANDERSON LN. Austin, TX 78752 -1793 |
| Contact | Teena M Augostino |
| Correspondent | Teena M Augostino VASCUTEK LTD. 1300-A 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 | 1995-05-16 |
| Decision Date | 1995-12-19 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05037881018171 | K952293 | 000 |
| 05037881018140 | K952293 | 000 |
| 05037881018119 | K952293 | 000 |
| 05037881018102 | K952293 | 000 |
| 05037881018089 | K952293 | 000 |
| 05037881018072 | K952293 | 000 |
| 05037881018065 | K952293 | 000 |
| 05037881007922 | K952293 | 000 |
| 05037881002286 | K952293 | 000 |