📋 FDA Reference

phoenix hemodialysis delivery system gambro cartridge for hemodialysis blood tubing set

Gambro Renal Products

FDA Clearance Information

Pathway 510K

Number K001156 ↗

Decision Date July 7, 2000

Product Code KDI

Device Class Class 2

Evidence 8 studies

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

The Phoenix Hemodialysis Delivery System is a sophisticated machine designed to perform hemodialysis, a process that removes waste products and excess fluid from the blood when the kidneys are not functioning properly. It works by circulating the patient’s blood through a dialyzer, where it is cleaned before being returned to the body. This system is essential for patients with chronic kidney disease or acute kidney injury requiring renal replacement therapy.

Clinical Applications

This device is commonly used in outpatient dialysis centers and hospitals. It is crucial for patients with end-stage renal disease (ESRD) who require regular dialysis sessions, typically three times a week. Nephrologists and dialysis nurses are the primary users, and it is also used in acute settings for patients with temporary kidney failure. The system is adaptable for both adult and pediatric populations.

Indications for Use

The Phoenix Hemodialysis Delivery System is indicated for patients with kidney failure who need hemodialysis to remove waste and excess fluid from their blood. It is suitable for those with chronic kidney disease or acute kidney injury.

Practical Considerations

The device is compatible with standard hemodialysis blood tubing sets and dialyzers. Clinicians should ensure proper setup and calibration before each session. Regular maintenance and checks are necessary to ensure optimal performance and patient safety.

Linked Studies (8)

PubMed • 2024

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 →

PubMed • 2024

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 →

PubMed • 2023

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 →

PubMed • 2022

Acute Real-World Outcomes From the Phoenix Post-Approval Registry.

The Journal of invasive cardiology

Other View Source →

PubMed • 2022

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 →

PubMed • 2020

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 →

PubMed • 2019

Hybrid atherectomy for lower extremity peripheral arterial disease.

Vascular

RCT|prospective|retrospective|case Series|other View Source →

PubMed • 2017

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.

Related Device Categories

Dialysis Access Devices