The following data is part of a premarket notification filed by Medtronic Vascular with the FDA for Cardioblate Gemini Surgical Ablation Device, Models 49260 And 49261.
| Device ID | K070311 |
| 510k Number | K070311 |
| Device Name: | CARDIOBLATE GEMINI SURGICAL ABLATION DEVICE, MODELS 49260 AND 49261 |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | MEDTRONIC VASCULAR 7601 NORTHLAND DRIVE Minneapolis, MN 55428 |
| Contact | Debbie Kidder |
| Correspondent | Mark Job REGULATORY TECHNOLOGY SERVICES, LLC 1000 Westgate Drive, Suite 510k Saint Paul, MN 55114 |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2007-02-01 |
| Decision Date | 2007-04-24 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00613994268075 | K070311 | 000 |
| 00613994268051 | K070311 | 000 |