510(k) K013392 ยท OCL Surgical Device, For Cutting, Coagulation, And/Or Ablation Of Tissue, Including Cardiac Tissue
CARDIOBLATE SURGICAL ABLATION PEN, MODEL 60811C; CARDIOBLATE SURGICAL ABLATION GENERATOR, MODEL 60880
| Applicant | Medtronic Vascular, Shoreview MN, US |
| Decision | Substantially Equivalent, Jan 25, 2002 |
| Received | Oct 15, 2001 |
| Type | Abbreviated |
| FDA record | Open on fda.gov |
Recalls that name K013392
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 11, 2002 | Medtronic Cardiac Surgery Technologies Medtronic Cardioblate Radio Frequency Ablation Pen, model number 60811C47 Terminated |
74 | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.