The following data is part of a premarket notification filed by Vascutek Ltd. with the FDA for Vascutek Gelsoft Plus Vascular Graft.
| Device ID | K955230 |
| 510k Number | K955230 |
| Device Name: | VASCUTEK GELSOFT PLUS 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 | 1995-11-14 |
| Decision Date | 1996-02-09 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05037881000480 | K955230 | 000 |
| 05037881115481 | K955230 | 000 |
| 05037881115474 | K955230 | 000 |
| 05037881115467 | K955230 | 000 |
| 05037881115450 | K955230 | 000 |
| 05037881115443 | K955230 | 000 |
| 05037881115436 | K955230 | 000 |
| 05037881115429 | K955230 | 000 |