The following data is part of a premarket notification filed by Cardima, Inc. with the FDA for Modification To: Cardima Ablation System.
| Device ID | K060715 |
| 510k Number | K060715 |
| Device Name: | MODIFICATION TO: CARDIMA ABLATION SYSTEM |
| Classification | Surgical Device, For Cutting, Coagulation, And/or Ablation Of Tissue, Including Cardiac Tissue |
| Applicant | CARDIMA, INC. 47266 BENICIA ST. Fremont, CA 94538 -1372 |
| Contact | Eric Chan |
| Correspondent | Eric Chan CARDIMA, INC. 47266 BENICIA ST. Fremont, CA 94538 -1372 |
| Product Code | OCL |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-03-17 |
| Decision Date | 2006-05-15 |
| Summary: | summary |