The following data is part of a premarket notification filed by Medtronic Inc. with the FDA for Cardioblate Bipolar Radiofrequency Surgical Ablation System, Models 60831, 60832, 60841.
| Device ID | K093203 |
| 510k Number | K093203 |
| Device Name: | CARDIOBLATE BIPOLAR RADIOFREQUENCY SURGICAL ABLATION SYSTEM, MODELS 60831, 60832, 60841 |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | MEDTRONIC INC. 710 MEDTRONIC PARKWAY NE Minneapolis, MN 55432 -5604 |
| Contact | Mary E Donlin |
| Correspondent | Mary E Donlin MEDTRONIC INC. 710 MEDTRONIC PARKWAY NE Minneapolis, MN 55432 -5604 |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-10-13 |
| Decision Date | 2010-02-26 |
| Summary: | summary |