The following data is part of a premarket notification filed by Medtronic Vascular with the FDA for Cardioblate Monopolar Pen, 60813, Cardioblate Monopolar Xl, 60814.
| Device ID | K070288 |
| 510k Number | K070288 |
| Device Name: | CARDIOBLATE MONOPOLAR PEN, 60813, CARDIOBLATE MONOPOLAR XL, 60814 |
| Classification | Surgical Device, For Cutting, Coagulation, And/or Ablation Of Tissue, Including Cardiac Tissue |
| Applicant | MEDTRONIC VASCULAR 7601 NORTHLAND DRIVE Minneapolis, MN 55428 |
| Contact | Scott Cundy |
| Correspondent | Scott Cundy MEDTRONIC VASCULAR 7601 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 | 2007-01-30 |
| Decision Date | 2007-06-18 |
| Summary: | summary |