The following data is part of a premarket notification filed by Sulzer Carbomedics, Inc. with the FDA for Sulzer Vascutek Gelweave Valsalva Vascular Prosthesis.
| Device ID | K013022 |
| 510k Number | K013022 |
| Device Name: | SULZER VASCUTEK GELWEAVE VALSALVA VASCULAR PROSTHESIS |
| Classification | Prosthesis, Vascular Graft, Of 6mm And Greater Diameter |
| Applicant | SULZER CARBOMEDICS, INC. 1300 EAST ANDERSON LN. Austin, TX 78752 |
| Contact | Lisa Peterson |
| Correspondent | Lisa Peterson SULZER CARBOMEDICS, INC. 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 | 2001-09-07 |
| Decision Date | 2002-06-13 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05037881999432 | K013022 | 000 |
| 05037881004723 | K013022 | 000 |
| 05037881004716 | K013022 | 000 |
| 05037881002538 | K013022 | 000 |
| 05037881002521 | K013022 | 000 |
| 05037881002514 | K013022 | 000 |
| 05037881002507 | K013022 | 000 |
| 05037881002491 | K013022 | 000 |
| 05037881002484 | K013022 | 000 |
| 05037881002187 | K013022 | 000 |
| 05037881002170 | K013022 | 000 |
| 05037881002163 | K013022 | 000 |
| 05037881002156 | K013022 | 000 |
| 05037881002149 | K013022 | 000 |
| 05037881004730 | K013022 | 000 |
| 05037881004747 | K013022 | 000 |
| 05037881004754 | K013022 | 000 |
| 05037881999425 | K013022 | 000 |
| 05037881998213 | K013022 | 000 |
| 05037881120294 | K013022 | 000 |
| 05037881120164 | K013022 | 000 |
| 05037881120157 | K013022 | 000 |
| 05037881120140 | K013022 | 000 |
| 05037881120133 | K013022 | 000 |
| 05037881120126 | K013022 | 000 |
| 05037881120119 | K013022 | 000 |
| 05037881106656 | K013022 | 000 |
| 05037881011110 | K013022 | 000 |
| 05037881004778 | K013022 | 000 |
| 05037881004761 | K013022 | 000 |
| 05037881002132 | K013022 | 000 |