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 |