Identity
- Trade Name
- Mi-Axus Catheter FDA UDI
- Generic Name
- Vascular guide-catheter, single-use FDA UDI
- Device Name
- The Mi-Axus 6F Distal Access Catheter is a single lumen, braided shaft, variable stiffness catheter with radiopaque marker on the distal end and a luer hub on the proximal end. The catheter shaft has a hydrophilic coating on the last 60 cm of the distal end. FDA UDI
- Model / Reference
- MIA-57112 FDA UDI
- Description
- The Mi-Axus 6F Distal Access Catheter is a single lumen, braided shaft, variable stiffness catheter with radiopaque marker on the distal end and a luer hub on the proximal end. The catheter shaft has a hydrophilic coating on the last 60 cm of the distal end. FDA UDI
Identifiers
- Primary DI / UDI-DI
- B293MIA571120 FDA UDI
- 510(k) Number
- K140557 FDA UDI
- FDA Product Code
- DQY FDA UDI
- GMDN Term
- Vascular guide-catheter, single-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 870.1250 FDA UDI
- Commercial Distribution
- Not in Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Dimensions & Sizes
- Size
- Catheter Gauge — 6 French FDA UDILength — 112 Centimeter FDA UDI
Mi-Axus Catheter by Mivi Neurovascular — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Mivi Neurovascular
Sources (1)
- FDA UDI 49ef7264-69b2-4114-a18a-1939dd80f683 37 fields · synced Jun 8, 2026