510(k) K200514 ยท OCL Surgical Device, For Cutting, Coagulation, And/Or Ablation Of Tissue, Including Cardiac Tissue
Cardioblate Gemini-s Surgical Ablation Device
| Applicant | Medtronic, Minneapolis MN, US |
| Decision | Substantially Equivalent, Jun 3, 2020 |
| Received | Mar 2, 2020 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K200514
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 20, 2022 | Medtronic Perfusion Systems Cardioblate" Gemini"-s Irrigated RF Surgical Ablation System; The device is placed in a plastic tray with a snap on plastic lid, the tray is placed in protective wrap, then into a sterile pouch, 1 dev Open, Classified |
OCL | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.