510(k) K123733 ยท OCL Surgical Device, For Cutting, Coagulation, And/Or Ablation Of Tissue, Including Cardiac Tissue
CARDIOBLATE CRYOFLEX SURGICAL ABLATION SYSTEM
| Applicant | Medtronic, Inc., Mounds View MN, US |
| Decision | Substantially Equivalent, Apr 1, 2013 |
| Received | Dec 5, 2012 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K123733
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 27, 2021 | Medtronic Perfusion Systems Cardioblate CryoFlex Surgical Ablation Console Open, Classified |
OCL | None listed |
| Oct 12, 2020 | MEDTRONIC ATS MEDICAL, INC. Cardioblate CryoFlex, Surgical Ablation Probe, Model Number 60SF2, PROBE 60SF2 CRYOFLEX 10CM 26L - Product Usage: is a single use, disposable cryoprobe that is designed for use with the CryoFlex Surgi Terminated |
OCL | None listed |
| Oct 12, 2020 | MEDTRONIC ATS MEDICAL, INC. Cardioblate CryoFlex, Surgical Ablation Probe, Model Number 60SF3, PROBE 60SF3 CRYOFLEX 10-S 26L - is a single use, disposable cryoprobe that is designed for use with the CryoFlex Surgical Ablation Sy Terminated |
OCL | None listed |
| Oct 12, 2020 | MEDTRONIC ATS MEDICAL, INC. Cardioblate CryoFlex, Surgical Ablation Probe, Model Number 60SF7, PROBE 60SF7 CRYOFLEX 7CM 26L - is a single use, disposable cryoprobe that is designed for use with the CryoFlex Surgical Ablation Sys Terminated |
OCL | None listed |
| Oct 12, 2020 | MEDTRONIC ATS MEDICAL, INC. Cardioblate CryoFlex, Surgical Ablation Probe, Model Number 60CM1, CLAMP 60CM1 CRYOFLEX PROBE 26L - is a single use, disposable cryoprobe that is designed for use with the CryoFlex Surgical Ablation S Terminated |
OCL | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.