The following data is part of a premarket notification filed by Medtronic Vascular with the FDA for Cardioblate Bipolar Radiofrequency Surgical Ablation System.
| Device ID | K031247 |
| 510k Number | K031247 |
| Device Name: | CARDIOBLATE BIPOLAR RADIOFREQUENCY SURGICAL ABLATION SYSTEM |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | MEDTRONIC VASCULAR 1015 GRAMSIE RD Shoreview, MN 55126 -3082 |
| Contact | Scott Cundy |
| Correspondent | Scott Cundy MEDTRONIC VASCULAR 1015 GRAMSIE RD Shoreview, MN 55126 -3082 |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-04-18 |
| Decision Date | 2003-07-17 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00613994334558 | K031247 | 000 |
| 00721902864292 | K031247 | 000 |
| 00885074359625 | K031247 | 000 |
| 00885074359618 | K031247 | 000 |
| 00885074266077 | K031247 | 000 |
| 00885074266022 | K031247 | 000 |