Asahi ViE-U Series Dialyzer
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identifiers
- 510(k) Number
- K162248 FDA 510(k)
- FDA Product Code
- KDI FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 876.5860 FDA 510(k)
- Regulation Number
- 876.5860 FDA 510(k)
- Advisory Committee
- Gastroenterology, Urology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Asahi ViE-U Series Dialyzer is a high-permeability hemodialysis device designed for blood purification in renal replacement therapy. It facilitates the removal of waste products, excess fluids, and toxins from the bloodstream through a semipermeable membrane during extracorporeal circulation.
This single-use, sterile device is intended for use in dialysis centers and hospitals, adhering to strict regulatory standards including FDA 510(k) clearance, MDD, and MDR compliance. Supplied in various sizes and configurations (as referenced by FEI numbers), it requires proper storage under controlled conditions to maintain sterility and functionality before use.
Frequently asked questions
What clinical purpose does the Asahi ViE-U Series Dialyzer serve in renal replacement therapy?
The Asahi ViE-U Series Dialyzer is designed for blood purification during hemodialysis, a key component of renal replacement therapy. It removes waste products, excess fluids, and toxins from the bloodstream via a high-permeability membrane during extracorporeal circulation. This makes it suitable for patients requiring dialysis to manage chronic kidney disease or acute kidney injury.
How many different sizes or configurations are available for the Asahi ViE-U Series, and how are they identified?
The Asahi ViE-U Series is supplied in multiple sizes and configurations, each identified by a unique FEI number (e.g., 3033903155, 3002806443, etc.). Over 50 distinct FEI numbers are listed, allowing for flexibility in selecting the appropriate dialyzer for patient-specific needs, such as blood flow rates or treatment duration.
Is the Asahi ViE-U Series Dialyzer intended for single-use or can it be reused?
The Asahi ViE-U Series Dialyzer is explicitly single-use only. It is supplied in a sterile package to ensure safety and efficacy for one-time use in dialysis procedures. Reuse is not recommended or supported by the manufacturer.
What storage conditions are required to maintain the sterility and functionality of the Asahi ViE-U Series Dialyzer before use?
The dialyzer must be stored under controlled conditions to preserve sterility and functionality. While the exact specifications (e.g., temperature, humidity) aren’t detailed here, standard practice for single-use medical devices like this typically requires storage in a clean, dry environment away from direct sunlight or extreme temperatures until ready for use. Always follow the manufacturer’s instructions provided with the packaging.
What regulatory pathways has the Asahi ViE-U Series Dialyzer undergone, and how does this affect its use in clinical settings?
The Asahi ViE-U Series Dialyzer has undergone FDA 510(k) clearance, as well as compliance with the Medical Device Directive (MDD) and Medical Device Regulation (MDR) in the EU. This means it has been evaluated for safety and performance against established standards, ensuring it meets regulatory requirements for use in dialysis centers and hospitals. Clinicians can rely on its compliance with these frameworks when integrating it into treatment protocols.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them.
Authorization Coverage (2 countries)
Regulatory Authorizations
MDD
MDR
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDD | — | Class II | Active |
| EUDAMED | European Union | MDR | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K162248 | Class II | Active |
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Manufacturer
- Manufacturer
- Asahi Kasei Medical Co., Ltd.
Sources (2)
- FDA 510(k) K162248 24 fields · synced Oct 6, 2026
- EUDAMED 1 fields · synced May 19, 2026