Duramax Hemodialysis Catheter and Procedure Kit
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K080400 FDA 510(k)
- FDA Product Code
- MSD FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 876.5540 FDA 510(k)
- Regulation Number
- 876.5540 FDA 510(k)
- Advisory Committee
- Gastroenterology, Urology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Duramax Hemodialysis Catheter and Procedure Kit is a Catheter, Hemodialysis, Implanted designed for long-term vascular access. It facilitates hemodialysis and apheresis procedures by providing reliable, sustained blood flow through implanted vascular access sites, reducing the need for repeated percutaneous access.
The kit is supplied sterile and intended for single-use, adhering to FDA 510(k) clearance under regulation number 876.5540. It is classified as a Class II medical device and includes components tested for tensile strength, leakage, flow rate, and compatibility. The catheter is intended for use in clinical settings such as dialysis centers and hospitals, with no MRI safety restrictions specified.
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. Sources consulted: PDF t '~I 'AngioDynamics, Inc. DuraMax®~ Chronic Hemodialysis Catheter and ..., Angiodynamics, Inc., Duramax Hemodialysis Catheter and Procedure Kit ..., PDF K080400 - Angiodynamics, Inc., Duramax Hemodialysis Catheter and ..., PDF t '~I 'AngioDynamics, Inc. DuraMax®~ Chronic Hemodialysis Catheter and ...
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K080400 | Class II | Active |
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Manufacturer
- Manufacturer
- Angiodynamics, Inc.
Sources (1)
- FDA 510(k) K080400 24 fields · synced Oct 6, 2026