The following data is part of a premarket notification filed by Medtronic Vascular with the FDA for U-clip Device, Model Nc65.
| Device ID | K062057 |
| 510k Number | K062057 |
| Device Name: | U-CLIP DEVICE, MODEL NC65 |
| Classification | Clip, Implantable |
| Applicant | MEDTRONIC VASCULAR 7611 NORTHLAND DR. Minneapolis, MN 55428 |
| Contact | David D Cox |
| Correspondent | David D Cox MEDTRONIC VASCULAR 7611 NORTHLAND DR. Minneapolis, MN 55428 |
| Product Code | FZP |
| CFR Regulation Number | 878.4300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-07-20 |
| Decision Date | 2006-08-02 |
| Summary: | summary |