Data / Medical devices / United States / Medtronic, Inc. (Minneapolis, MN 55447)
Medtronic, Inc. (Minneapolis, MN 55447): FDA-registered device maker in Minneapolis, MN, United States, 2 510(k) clearances and 1 PMA approval
Medtronic, Inc. (Minneapolis, MN 55447) is registered with the FDA (registration 3008592544) in Minneapolis, MN, United States. It lists 4 device types. The FDA files 2 510(k) clearances and 1 PMA approval under its listings, the newest dated April 1, 2013. 4 recall events name it as the recalling firm. Registered through 2026. FDA data exported November 3, 2026.
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- FDA registration number
- 3008592544
- Address
- 3800 Annapolis Lane, Minneapolis, MN, United States, 55447
- Owner or operator
- Medtronic, Inc. (2112641)
- Roles
- Manufacturer
- First device listed
- July 30, 1992
- Registered through
- 2026
- Brand names listed
- AORTIC CUFF, ATRIAL LIFT SYSTEM, ATS Open Pivot Bi-leaflet, Accessory Port ATS Medical Thoracic Port System, Actuators, Adjustable Slitter, Avalus Valve Handle, CG Future Handle and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Heart-Valve, Mechanical | LWQ | 3 | Manufacturer | accessdata.fda.gov |
| Holder, Heart-Valve, Prosthesis | DTJ | 1 | Manufacturer | accessdata.fda.gov |
| Instruments, Surgical, Cardiovascular | DWS | 1 | Manufacturer | accessdata.fda.gov |
| Surgical Device, For Cutting, Coagulation, And/Or Ablation Of Tissue, Including Cardiac Tissue | OCL | 2 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| April 1, 2013 | K123733 | CARDIOBLATE CRYOFLEX SURGICAL ABLATION SYSTEM | OCL | Substantially Equivalent | Medtronic, Inc. | accessdata.fda.gov |
| November 2, 2012 | K121878 | CARDIOBLATE CRYOFLEX SURGICAL ABLATION PROBES | OCL | Substantially Equivalent | Medtronic, Inc. | accessdata.fda.gov |
PMA approvals
Premarket approvals this establishment lists, with the supplements the FDA has decided since.
| Approved | PMA number | Device | Product code | Supplements | Latest decision | Source |
|---|---|---|---|---|---|---|
| October 13, 2000 | P990046 | ATS OPEN PIVOT BILEAFLET HEART VALVE | LWQ | 59 | November 7, 2023 | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| October 12, 2020 | 86666 | Class II | Terminated | 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 Surgical Ablation System. | There is a potential defect in the seals of the sterile barrier pouch used to package the CryoFlex disposables devices | accessdata.fda.gov |
| February 11, 2020 | 85092 | Class II | Terminated | Medtronic Open Pivot Aortic Valve Graft, REF 502AG25, SIZE 25 mm | Medtronic received a complaint from China that the label on the box for an Open Pivot Heart Valve was labeled as Aortic, but the product was Mitral. The valve itself was correctly labeled as Mitral. | accessdata.fda.gov |
| May 5, 2006 | 35745 | Not yet classified | Terminated | CryoCath Frost Byte CryoSurgical Clamp, Model 60FB1, Manufacturer CryoCath Technologies, Inc., Quebec, Canada. The product consists of a cryosurgical probe (SurgiFrost 7 cm) plus Clamp (FrostByte) packaged for use with C | Incorrect Expiration Date: Three lots of the FrostByte (TM) clamp packaged with SurgiFrost 7 cm cryosurgical probes have incorrect expiration dates. These lots are labeled with a two (2) year expiratation date while the correct date is one (1) year. | accessdata.fda.gov |
| February 18, 2004 | 28356 | Not yet classified | Terminated | ATS Open Pivot Mechanical Heart Valve | Normally functioning prosthesis may have been placed on the valve holder mechanism in reverse position. | accessdata.fda.gov |
Compare with other makers
- All makers of Heart-Valve, Mechanical
- All makers of Surgical Device, For Cutting, Coagulation, And/Or Ablation Of Tissue, Including Cardiac Tissue
- All makers of Holder, Heart-Valve, Prosthesis
- All makers of Instruments, Surgical, Cardiovascular
Updated November 7, 2023. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.