The following data is part of a premarket notification filed by Medtronic Inc. with the FDA for Cardioblate Gemini Surgical Ablation Device.
| Device ID | K121767 |
| 510k Number | K121767 |
| Device Name: | CARDIOBLATE GEMINI SURGICAL ABLATION DEVICE |
| Classification | Surgical Device, For Cutting, Coagulation, And/or Ablation Of Tissue, Including Cardiac Tissue |
| Applicant | MEDTRONIC INC. 8200 Coral Sea Street NE Mounds View, MN 55112 |
| Contact | Mary E Donlin |
| Correspondent | Mary E Donlin MEDTRONIC INC. 8200 Coral Sea Street NE Mounds View, MN 55112 |
| Product Code | OCL |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-06-15 |
| Decision Date | 2012-07-13 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00763000841591 | K121767 | 000 |