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Sign in to claim this brandMedtronic Core Valve, LLC
US
Last updated May 23, 2026
What Medtronic Core Valve, LLC makes
Medtronic Core Valve, LLC designs and manufactures transcatheter aortic valve replacements (TAVR) with stent-like bioprosthetic frameworks. These devices are intended for percutaneous implantation in patients with aortic stenosis, offering minimally invasive alternatives to surgical valve replacement.
The company’s portfolio includes Class II and Class III devices, authorised via FDA 510(k) and UDI pathways. Products are listed in the FDA’s regulatory databases, and the company operates from the United States.
Written from this company's registered devices by an AI model, and not verified by a human reviewer.
Frequently asked questions
What types of medical devices does Medtronic Core Valve, LLC specialize in?
Medtronic Core Valve, LLC specializes in transcatheter aortic valve replacements (TAVR), specifically aortic transcatheter heart valve bioprostheses with stent-like frameworks. These devices are designed for percutaneous (through-the-skin) implantation in patients with aortic stenosis, providing a less invasive option compared to traditional surgical valve replacement. The company’s focus is on Class II and Class III devices, which are authorised through regulatory pathways like the FDA’s 510(k) and UDI processes.
Where is Medtronic Core Valve, LLC based?
Medtronic Core Valve, LLC is based in the United States. The company’s headquarters and operations are located within the country, though specific regional offices or manufacturing sites may vary. This location aligns with its regulatory submissions and compliance requirements, including listings in the FDA’s databases.
Which regulatory registries or databases list Medtronic Core Valve, LLC’s devices?
Medtronic Core Valve, LLC’s devices are listed in the FDA’s regulatory databases, specifically through the 510(k) premarket notification pathway and the Unique Device Identifier (UDI) system. These registries ensure transparency and traceability of authorised devices, allowing healthcare providers, regulators, and patients to access critical information about the company’s transcatheter heart valve products.
How are Medtronic Core Valve, LLC’s devices classified under FDA regulations?
Medtronic Core Valve, LLC’s devices fall into both Class II and Class III categories under FDA regulations. Class III devices, such as certain transcatheter heart valves, require pre-market approval (PMA) due to their higher risk and life-sustaining or life-supporting nature, while Class II devices may undergo 510(k) clearance if they are substantially equivalent to a predicate device. The classification depends on factors like the device’s intended use, potential risks, and the degree of innovation compared to existing solutions.
What is the primary purpose of the devices manufactured by Medtronic Core Valve, LLC?
The primary purpose of Medtronic Core Valve, LLC’s devices is to treat aortic stenosis—a condition where the heart’s aortic valve narrows, restricting blood flow—through minimally invasive transcatheter procedures. These bioprosthetic valves with stent-like frameworks are implanted via catheterisation, offering patients an alternative to open-heart surgery. The devices are designed to restore normal blood flow and alleviate symptoms associated with severe aortic stenosis, improving quality of life and reducing the need for surgical intervention.
AI-generated from registry data and not verified by a human reviewer.
Information
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- US
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Catalogue (73)
Page 2 of 2| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| CoreValve™ Evolut™ | MCS-P4-23-AOA-US | FDA UDI | Class III | Unknown |
| CoreValve™ Evolut™ | MCS-P3-31-AOA | FDA UDI | Class III | Unknown |
| CoreValve™ Evolut™ | MCS-P3-26-AOA | FDA UDI | Class III | Unknown |
| Evolut™ PRO+ | EVPROPLUS-23US | FDA UDI | Class III | Active |
| Evolut™ FX | L-EVOLUTFX-34 | FDA UDI | Class III | Active |
| CoreValve™ Evolut™ PRO | EVOLUTPRO-23-US | FDA UDI | Class III | Active |
| Evolut™ FX | EVOLUTFX-23 | FDA UDI | Class III | Active |
| Evolut™ FX | L-EVOLUTFX-34 | FDA UDI | Class III | Active |
| CoreValve™ | DCS-C4-18F-23US | FDA UDI | Class III | Unknown |
| Evolut™ PRO+ | D-EVPROP2329US | FDA UDI | Class III | Active |
| EnVeo™ R | LS-ENVEOR-34-US | FDA UDI | Class III | Active |
| CoreValve™ Evolut™ R | EVOLUTR-26-US | FDA UDI | Class III | Active |
| CoreValve™ Evolut™ | MCS-P4-23-AOA | FDA UDI | Class III | Unknown |
| CoreValve™ Evolut™ PRO | EVOLUTPRO-29-US | FDA UDI | Class III | Active |
| CoreValve™ Evolut™ R | EVOLUTR-29-US | FDA UDI | Class III | Active |
| CoreValve™ Evolut™ | MCS-P3-29-AOA-US | FDA UDI | Class III | Unknown |
| CoreValve™ Evolut™ | MCS-P4-23-AOA-US | FDA UDI | Class III | Unknown |
| EnVeo™ R | LS-MDT2-2629-US | FDA UDI | Class III | Active |
| CoreValve™ Evolut™ R | EVOLUTR-34-US | FDA UDI | Class III | Active |
| CoreValve™ Evolut™ | MCS-P3-26-AOA | FDA UDI | Class III | Unknown |
| CoreValve™ Evolut™ | MCS-P3-26-AOA-US | FDA UDI | Class III | Unknown |
| Medtronic Confida Brecker Guidewire | K150465 | FDA 510(k) | Class II | Active |
| Medtronic Confida Brecker Guidewire | K181001 | FDA 510(k) | Class II | Active |
Related Companies
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FDA Recalls (2)
Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.
Medtronic Core Valve, LLC has two recall records, both initiated on January 14, 2020. The records are marked with open and classified statuses. The reasons provided state that Demonstration Simulus Reusable Sizer Accessory Kits were incorrectly distributed to customers, with the potential for the demonstration product—used in a wet lab—to have come into contact with non-human (porcine) tissue.
AI-generated summary of the recall records listed below. It describes what the records state and is not an assessment of this manufacturer.
| Date | Recall No. | Class | Status | Reason |
|---|---|---|---|---|
| Jan 14, 2020 | Z-1450-2020 | — | open, classified | Demonstration Simulus Reusable Sizer Accessory Kits were being incorrectly sourced to customers. The demonstration product (product used within a wet lab) could have come in contact with non-human (porcine) tissue. |
| Jan 14, 2020 | Z-1449-2020 | — | open, classified | Demonstration Simulus Reusable Sizer Accessory Kits were being incorrectly sourced to customers. The demonstration product (product used within a wet lab) could have come in contact with non-human (porcine) tissue. |