Phoenix Hemodialysis Delivery System, Version 3.35
FDA 510(k)Class II (US FDA 510(k))
by Gambro, Inc.
Identifiers
- 510(k) Number
- K070643 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 Phoenix Hemodialysis Delivery System, Version 3.35 is a Dialyzer, High Permeability With or Without Sealed Dialysate System (product code KDI), designed for hemodialysis, hemofiltration, and ultrafiltration. It facilitates the removal of waste products and excess fluids from a patient’s blood through semipermeable membranes, enabling high-flux and low-flux treatments in renal replacement therapy.
This system is intended for use in clinical settings, such as dialysis centers, and is regulated under FDA 510(k) clearance (K070643) as a Class II medical device. It operates as a reusable device, adhering to strict regulatory standards for hemodialysis equipment. The system’s compatibility with MRI environments and specific size configurations are not detailed in the provided data, but its use is governed by the FDA’s classification under regulation number 876.5860.
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: K070643 FDA 510 (k) - PHOENIX HEMODIALYSIS DELIVERY SYSTEM, Phoenix Hemodialysis Delivery System, Version 3.35 (K070643) — Fda 510 ..., Phoenix Hemodialysis Delivery System, Version 3.35, PDF K070643 - Phoenix Hemodialysis Delivery System, Version 3, Recall of PHOENIX HEMODIALYSIS DELIVERY SYSTEM
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K070643 | Class II | Active |
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Manufacturer
- Manufacturer
- Gambro, Inc.
Sources (1)
- FDA 510(k) K070643 24 fields · synced Sep 19, 2026