The following data is part of a premarket notification filed by Sulzermedica with the FDA for Sulzer Vascutek Gelsoft Vascular Prosthesis.
| Device ID | K990503 |
| 510k Number | K990503 |
| Device Name: | SULZER VASCUTEK GELSOFT VASCULAR PROSTHESIS |
| Classification | Prosthesis, Vascular Graft, Of 6mm And Greater Diameter |
| Applicant | SULZERMEDICA 1300 EAST ANDERSON LN. Austin, TX 78752 |
| Contact | Edward E Newton |
| Correspondent | Edward E Newton SULZERMEDICA 1300 EAST ANDERSON LN. Austin, TX 78752 |
| Product Code | DSY |
| CFR Regulation Number | 870.3450 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-02-17 |
| Decision Date | 1999-12-09 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05037881999463 | K990503 | 000 |
| 05037881020297 | K990503 | 000 |
| 05037881020280 | K990503 | 000 |
| 05037881020273 | K990503 | 000 |
| 05037881020266 | K990503 | 000 |
| 05037881020259 | K990503 | 000 |
| 05037881020242 | K990503 | 000 |
| 05037881020235 | K990503 | 000 |
| 05037881020228 | K990503 | 000 |
| 05037881020211 | K990503 | 000 |
| 05037881020303 | K990503 | 000 |
| 05037881020426 | K990503 | 000 |
| 05037881020433 | K990503 | 000 |
| 05037881999456 | K990503 | 000 |
| 05037881999449 | K990503 | 000 |
| 05037881110578 | K990503 | 000 |
| 05037881110561 | K990503 | 000 |
| 05037881110554 | K990503 | 000 |
| 05037881110547 | K990503 | 000 |
| 05037881020556 | K990503 | 000 |
| 05037881020457 | K990503 | 000 |
| 05037881020440 | K990503 | 000 |
| 05037881020204 | K990503 | 000 |