The following data is part of a premarket notification filed by Vescare, Inc. with the FDA for Graftsaver.
| Device ID | K043515 |
| 510k Number | K043515 |
| Device Name: | GRAFTSAVER |
| Classification | Catheter, Irrigation |
| Applicant | VESCARE, INC. 28 COOK ST. Billerica, MA 01821 |
| Contact | David Walsh |
| Correspondent | David Walsh VESCARE, INC. 28 COOK ST. Billerica, MA 01821 |
| Product Code | GBX |
| CFR Regulation Number | 878.4200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-12-20 |
| Decision Date | 2005-03-31 |
| Summary: | summary |