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 |