The following data is part of a premarket notification filed by Medtronic Vascular with the FDA for U-clip Device, Models B140, B160 And B180.
| Device ID | K053252 |
| 510k Number | K053252 |
| Device Name: | U-CLIP DEVICE, MODELS B140, B160 AND B180 |
| Classification | Clip, Implantable |
| Applicant | MEDTRONIC VASCULAR 1015 GRAMSIE RD Shoreview, MN 55126 -3082 |
| Contact | David D Cox |
| Correspondent | David D Cox MEDTRONIC VASCULAR 1015 GRAMSIE RD Shoreview, MN 55126 -3082 |
| Product Code | FZP |
| CFR Regulation Number | 878.4300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-11-21 |
| Decision Date | 2005-12-16 |
| Summary: | summary |