The following data is part of a premarket notification filed by Medtronic with the FDA for Cardioblate Maps Surgical Mapping, Ablation, Pacing And Sensing Device, Model 49205.
| Device ID | K090721 |
| 510k Number | K090721 |
| Device Name: | CARDIOBLATE MAPS SURGICAL MAPPING, ABLATION, PACING AND SENSING DEVICE, MODEL 49205 |
| Classification | Surgical Device, For Cutting, Coagulation, And/or Ablation Of Tissue, Including Cardiac Tissue |
| Applicant | Medtronic 8200 CORAL SEA STREET NE Minneapolis, MN 55428 |
| Contact | Peter Liu |
| Correspondent | Peter Liu Medtronic 8200 CORAL SEA STREET NE 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 | 2009-03-18 |
| Decision Date | 2009-06-16 |
| Summary: | summary |