The following data is part of a premarket notification filed by Medtronic with the FDA for Valleylab Ft10 Electrosurgical Platform, Cardioblate Bp2 Surgical Ablation Device, Cardioblate Lp Surgical Ablation Device.
| Device ID | K182610 |
| 510k Number | K182610 |
| Device Name: | Valleylab FT10 Electrosurgical Platform, Cardioblate BP2 Surgical Ablation Device, Cardioblate LP Surgical Ablation Device |
| Classification | Surgical Device, For Cutting, Coagulation, And/or Ablation Of Tissue, Including Cardiac Tissue |
| Applicant | Medtronic 7611 Northland Drive Minneapolis, MN 55428 |
| Contact | Kari Christianson |
| Correspondent | Kari Christianson Medtronic 7611 Northland Drive Minneapolis, MN 55428 |
| Product Code | OCL |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-09-21 |
| Decision Date | 2018-12-19 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00643169998018 | K182610 | 000 |
| 00643169997998 | K182610 | 000 |