Company
MEDTRONIC ATS MEDICAL, INC.
FDA 510(k) clearances and medical device recalls filed under this name. Name variants (Inc, Corp, punctuation) are merged.
0510(k) clearances (0 in 12 months)
5recalls (0 in 12 months)
4recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| No clearances in this window. | |||
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| 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 | K123733 |
| 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 | K123733 |
| 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 | K123733 |
| 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 | K123733 |
| Feb 11, 2020 | MEDTRONIC ATS MEDICAL, INC. Medtronic Open Pivot Aortic Valve Graft, REF 502AG25, SIZE 25 mm Terminated |
LWQ | None listed |