510(k) K060715 ยท OCL Surgical Device, For Cutting, Coagulation, And/Or Ablation Of Tissue, Including Cardiac Tissue
MODIFICATION TO: CARDIMA ABLATION SYSTEM
| Applicant | Cardima, Inc., Fremont CA, US |
| Decision | Substantially Equivalent, May 15, 2006 |
| Received | Mar 17, 2006 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K060715
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 27, 2010 | Cardima Inc Cardima Surgical Ablation Probe (SAP) Electrosurgical cutting and coagulation device, Model Number 01-242208, manufactured by Cardima Inc, Fremont, CA Terminated |
OCL | None listed |
| Sep 27, 2010 | Cardima Inc Cardima Surgical Ablation Probe (SAP) Electrosurgical cutting and coagulation device, Model Number 01-242208, manufactured by Cardima Inc, Fremont, CA Terminated |
OCL | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.