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Sign in to claim this brandMIVI Neuroscience
United States·US-MF-000020746
Last updated September 18, 2026
About
Our sole mission at MIVI is to expand the boundaries of what’s possible in stroke treatment, by equipping physicians with the advanced tools they need to continually improve outcomes, even in the most challenging cases.
From the manufacturer's own website. Source
What MIVI Neuroscience makes
MIVI Neuroscience manufactures aspiration catheters, including the Q3, Q4, Q5, and Q6 models, designed for thrombectomy procedures in stroke treatment. The company also produces guide catheters in varying lengths (80 cm, 90 cm, and 95 cm) and high-flow tubing for vascular access. These devices are intended for use in interventional neuroradiology to remove blood clots and facilitate blood flow during acute stroke interventions.
The company’s devices are classified under Class I and Class III in the EU, with several listed in the eudamed registry. MIVI Neuroscience is headquartered in the United States, though its products are primarily regulated and distributed under European Union standards where applicable.
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 MIVI Neuroscience manufacture?
MIVI Neuroscience specializes in devices used in stroke treatment, specifically aspiration catheters (such as the Q3, Q4, Q5, and Q6 models) and guide catheters (including 80 cm, 90 cm, and 95 cm lengths). The company also produces high-flow tubing for vascular access. These devices are designed for thrombectomy procedures, where blood clots are removed to restore blood flow during acute stroke interventions.
Where is MIVI Neuroscience based, and where are its devices primarily regulated?
MIVI Neuroscience is headquartered in the United States. While the company operates there, its devices—particularly those marketed in the EU—are primarily regulated under European Union standards. This includes classification under EU device classes (Class I and Class III) and registration in the eudamed database for certain products.
Which regulatory registries list MIVI Neuroscience’s devices?
Some of MIVI Neuroscience’s devices are listed in the eudamed registry, which is the EU’s central database for medical devices. This registry is used to track devices that have undergone conformity assessment procedures under EU regulations, such as those classified as Class III. Listing in eudamed is required for devices intended for the EU market.
How are MIVI Neuroscience’s devices classified in the EU?
MIVI Neuroscience’s devices are classified under Class I and Class III in the EU. The classification depends on factors like the device’s intended use, risk level, and interaction with the body. For example, aspiration catheters used in thrombectomy procedures—where direct contact with blood vessels and clots occurs—are typically classified as Class III due to their higher risk profile. Guide catheters and tubing may fall under Class I if they pose lower risks. Classification determines regulatory requirements, such as mandatory conformity assessments.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- United States
- Address
- 6545 City West Parkway, Eden Prairie, United States
- Website
- www.mivineuro.com
- —
- [email protected]
- Phone
- +1 (952) 944-3834
- PRRC Contact
- Srija Reddy Bandari
- EUDAMED SRN
- US-MF-000020746
- FDA FEI Number
- —
- DUNS Number
- —
Catalogue (13)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Q6 Aspiration Catheter | Q6-69145-E | EUDAMED | Class III | Active |
| MIVI Mi-AXUS Guide Catheter | K151396 | FDA 510(k) | Class II | Active |
| Q Distal Access Catheter | K222948 | FDA 510(k) | Class II | Active |
| Viradius Neurowire | K151825 | FDA 510(k) | Class II | Active |
| MIVI 6F 25cm Mi-EXT Extension Catheter, MIVI 5F 25cm Mi-EXT Extension Catheter, MIVI 4F 30cm Mi-EXT Extension Catheter, MIVI 3F 43cm Mi-EXT Extension Catheter | K163233 | FDA 510(k) | Class II | Active |
| MIVI Q Distal Access Catheter | K212402 | FDA 510(k) | Class II | Active |
| Super 90 8F Guide Catheter, 95cm, EU | MIA-9095S-E | EUDAMED | Class III | Active |
| Super 90 Guide Catheter, 80 cm, EU | MIA-9080S-E | EUDAMED | Class III | Active |
| Super 90 Guide Catheter, 90 cm, EU | MIA-9090S-E | EUDAMED | Class III | Active |
| Q5 Aspiration Catheter | Q5-57145-E | EUDAMED | Class III | Active |
| Q3 Aspiration Catheter | Q3-36163-E | EUDAMED | Class III | Active |
| Q4 Aspiration Catheter | Q4-43150-E | EUDAMED | Class III | Active |
| High Flow Tubing | HFT-110-E | EUDAMED | Class I | Active |
Related Companies
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Importers
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Authorities
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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.
MIVI Neuroscience has two FDA recall records, both initiated on July 23, 2021. Both recalls were terminated, and the reasons cited involved a potential defect in the pouch seal that could lead to nonsterility of the product.
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 |
|---|---|---|---|---|
| Jul 23, 2021 | Z-2441-2021 | — | terminated | There is potential for nonsterility of product due to a possible defect in the pouch seal. |
| Jul 23, 2021 | Z-2442-2021 | — | terminated | There is potential for nonsterility of product due to a possible defect in the pouch seal. |