The following data is part of a premarket notification filed by Medtronic with the FDA for Cardioblate Pen Surgical Ablation Device, Cardioblate Xl Pen Surgical Ablation Device.
| Device ID | K190623 |
| 510k Number | K190623 |
| Device Name: | Cardioblate Pen Surgical Ablation Device, Cardioblate XL Pen 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 | Rahul Shah |
| Correspondent | Rahul Shah 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 | 2019-03-11 |
| Decision Date | 2019-05-30 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00643169997974 | K190623 | 000 |
| 00643169997967 | K190623 | 000 |