The following data is part of a premarket notification filed by Medtronic Inc. with the FDA for Cardioblate Surgical Ablation Generator, Model 68000; Cardioblate Bp2 Surgical Ablation Device, Model 60831; Cardioblat.
| Device ID | K060400 |
| 510k Number | K060400 |
| Device Name: | CARDIOBLATE SURGICAL ABLATION GENERATOR, MODEL 68000; CARDIOBLATE BP2 SURGICAL ABLATION DEVICE, MODEL 60831; CARDIOBLAT |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | MEDTRONIC INC. 7601 NORTHLAND DRIVE Minneapolis, MN 55428 |
| Contact | David D Cox |
| Correspondent | Silvia Ankova UNDERWRITERS LABORATORIES, INC. 333 PFINGSTEN RD. Northbrook, IL 60062 |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2006-02-15 |
| Decision Date | 2006-02-28 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00613994334565 | K060400 | 000 |
| 00613994299413 | K060400 | 000 |