The following data is part of a premarket notification filed by St. Jude Medical with the FDA for Epicor Ablation System.
| Device ID | K080292 |
| 510k Number | K080292 |
| Device Name: | EPICOR ABLATION SYSTEM |
| Classification | Surgical Device, For Cutting, Coagulation, And/or Ablation Of Tissue, Including Cardiac Tissue |
| Applicant | ST. JUDE MEDICAL 1350 ENERGY LN., SUITE 110 St. Paul, MN 55108 |
| Contact | Karen J Mckelvey |
| Correspondent | Karen J Mckelvey ST. JUDE MEDICAL 1350 ENERGY LN., SUITE 110 St. Paul, MN 55108 |
| Product Code | OCL |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-02-04 |
| Decision Date | 2008-07-25 |
| Summary: | summary |