The following data is part of a premarket notification filed by Medtronic Inc. with the FDA for Cardioblate Maps Surgical Mapping, Ablation, Pacing , And Sensing Device.
Device ID | K121451 |
510k Number | K121451 |
Device Name: | CARDIOBLATE MAPS SURGICAL MAPPING, ABLATION, PACING , AND SENSING DEVICE |
Classification | Surgical Device, For Cutting, Coagulation, And/or Ablation Of Tissue, Including Cardiac Tissue |
Applicant | MEDTRONIC INC. 8200 Coral Sea Street NE Mounds View, MN 55112 |
Contact | Mary Donlin |
Correspondent | Mary Donlin MEDTRONIC INC. 8200 Coral Sea Street NE Mounds View, MN 55112 |
Product Code | OCL |
CFR Regulation Number | 878.4400 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2012-05-16 |
Decision Date | 2012-06-14 |
Summary: | summary |