510(k) K121767 ยท OCL Surgical Device, For Cutting, Coagulation, And/Or Ablation Of Tissue, Including Cardiac Tissue
CARDIOBLATE GEMINI SURGICAL ABLATION DEVICE
| Applicant | Medtronic, Inc., Mounds View MN, US |
| Decision | Substantially Equivalent, Jul 13, 2012 |
| Received | Jun 15, 2012 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K121767
| 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.