The following data is part of a premarket notification filed by Sulzer Carbomedics, Inc. with the FDA for Sulzer Vascutek Gelsoft Ers Vascular Prosthesis.
| Device ID | K002007 |
| 510k Number | K002007 |
| Device Name: | SULZER VASCUTEK GELSOFT ERS VASCULAR PROSTHESIS |
| Classification | Prosthesis, Vascular Graft, Of 6mm And Greater Diameter |
| Applicant | SULZER CARBOMEDICS, INC. 1300 EAST ANDERSON LN. Austin, TX 78752 |
| Contact | Lisa O'conner |
| Correspondent | Lisa O'conner 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 | 2000-07-03 |
| Decision Date | 2001-01-25 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05037881115627 | K002007 | 000 |
| 05037881110653 | K002007 | 000 |
| 05037881110646 | K002007 | 000 |
| 05037881110639 | K002007 | 000 |
| 05037881110622 | K002007 | 000 |
| 05037881110615 | K002007 | 000 |
| 05037881110608 | K002007 | 000 |
| 05037881101262 | K002007 | 000 |
| 05037881101255 | K002007 | 000 |
| 05037881101248 | K002007 | 000 |
| 05037881101231 | K002007 | 000 |
| 05037881110660 | K002007 | 000 |
| 05037881110677 | K002007 | 000 |
| 05037881110684 | K002007 | 000 |
| 05037881115610 | K002007 | 000 |
| 05037881115603 | K002007 | 000 |
| 05037881110776 | K002007 | 000 |
| 05037881110769 | K002007 | 000 |
| 05037881110752 | K002007 | 000 |
| 05037881110738 | K002007 | 000 |
| 05037881110721 | K002007 | 000 |
| 05037881110714 | K002007 | 000 |
| 05037881110707 | K002007 | 000 |
| 05037881110691 | K002007 | 000 |
| 05037881101224 | K002007 | 000 |