Phoenix Hemodialysis Delivery System Gambro Cartridge for Hemodialysis Blood Tubing Set
Gambro Renal Products
FDA Clearance Information
The Phoenix Hemodialysis Delivery System by Gambro Renal Products was cleared through the FDA 510(k) pathway on July 7, 2000. It is classified as a Class 2 device under product code KDI.
What It Is
FDA-Cleared Indications
- Use during hemodialysis treatment for patients who require extracorporeal blood purification.
- Use with compatible hemodialysis blood tubing sets, dialyzers, and dialysis fluids as part of a hemodialysis system.
- Use to remove waste products and excess fluid from the blood when kidney function is inadequate.
Clinical Applications
- Routine hemodialysis for patients with kidney failure or end-stage kidney disease.
- Hemodialysis in a hospital or outpatient dialysis center.
- Hemodialysis for patients with acute kidney injury when renal replacement therapy is required.
- Extracorporeal circulation of blood through a dialyzer and return of treated blood to the patient.
Practical Considerations
- The system is used with compatible blood tubing sets, dialyzers, dialysis fluids, and other required dialysis accessories; compatibility should be confirmed before treatment.
- Blood access may be through an arteriovenous fistula, arteriovenous graft, or temporary or tunneled dialysis catheter, depending on the patient.
- The device requires trained dialysis personnel to prime the circuit, program treatment parameters, monitor pressures and alarms, and check for blood leaks or clotting.
- This is an extracorporeal blood-circulation system and should not be considered MRI safe while connected to a patient or containing blood; MRI compatibility depends on the specific configuration and components.
- Treatment may be unsuitable or require modification in patients with unstable blood pressure, inadequate vascular access, active bleeding, severe coagulopathy, or other contraindications to hemodialysis.
Linked Studies (8)
Multicenter comparison of Etest, Vitek2 and BD Phoenix to broth microdilution for beta-lactam susceptibility testing of Streptococcus pneumonia.
European journal of clinical microbiology & infectious diseases : official publication of the European Society of Clinical Microbiology
RCT|prospective|retrospective|case Series|other View Source →Safety and effectiveness of the Phoenix atherectomy device for endovascular treatment of common femoral and popliteal arteries: Results of the EN-MOBILE trial.
Vascular medicine (London, England)
View Source →Crossing complex infrapopliteal lesions utilizing a front-end cutting technique: A report of two cases with a novel rotational atherectomy device.
SAGE open medical case reports
View Source →Acute Real-World Outcomes From the Phoenix Post-Approval Registry.
The Journal of invasive cardiology
Other View Source →Phoenix atherectomy for patients with peripheral artery disease.
EuroIntervention : journal of EuroPCR in collaboration with the Working Group on Interventional Cardiology of the European Society of Cardiology
RCT|prospective|retrospective|case Series|other View Source →A Single-Center Experience With Phoenix Atherectomy System in Patients With Moderate to Heavily Calcified Femoropopliteal Lesions.
Cardiovascular revascularization medicine : including molecular interventions
RCT|prospective|retrospective|case Series|other View Source →Hybrid atherectomy for lower extremity peripheral arterial disease.
Vascular
RCT|prospective|retrospective|case Series|other View Source →Safety and effectiveness of the Phoenix Atherectomy System in lower extremity arteries: Early and midterm outcomes from the prospective multicenter EASE study.
Vascular
View Source →Frequently Asked Questions
What is the Phoenix Hemodialysis Delivery System used for?
It is used for performing hemodialysis to remove waste and excess fluids from the blood in patients with kidney failure.
What specialties typically use this device?
Nephrology is the primary specialty that uses this device, particularly in dialysis centers and hospital settings.
What are the FDA-cleared indications?
It is indicated for patients with kidney failure who require hemodialysis to manage waste and fluid levels in their blood.