The following data is part of a premarket notification filed by Medtronic Vascular with the FDA for Cardioblate Dispersive Electrode Adapter (accessory), Model 60884.
| Device ID | K043291 |
| 510k Number | K043291 |
| Device Name: | CARDIOBLATE DISPERSIVE ELECTRODE ADAPTER (ACCESSORY), MODEL 60884 |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | MEDTRONIC VASCULAR 1015 GRAMSIE RD Shoreview, MN 55126 -3082 |
| Contact | David D Cox |
| Correspondent | David D Cox MEDTRONIC VASCULAR 1015 GRAMSIE RD Shoreview, MN 55126 -3082 |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-11-29 |
| Decision Date | 2004-12-21 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00885074243092 | K043291 | 000 |