The following data is part of a premarket notification filed by Sunwei Tech Co. Ltd. with the FDA for Vasoring* Vrc Vascular Ring Connector.
| Device ID | K061626 |
| 510k Number | K061626 |
| Device Name: | VASORING* VRC VASCULAR RING CONNECTOR |
| Classification | Prosthesis, Vascular Graft, Of 6mm And Greater Diameter |
| Applicant | SUNWEI TECH CO. LTD. 7128 STAFFORDSHIRE STREET Houston, TX 77030 |
| Contact | Joseph J Chang |
| Correspondent | Joseph J Chang SUNWEI TECH CO. LTD. 7128 STAFFORDSHIRE STREET Houston, TX 77030 |
| Product Code | DSY |
| CFR Regulation Number | 870.3450 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-06-12 |
| Decision Date | 2006-10-05 |
| Summary: | summary |