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Phoenix Hemodialysis Delivery System Version 3 35
Gambro
Summary: The Phoenix Hemodialysis Delivery System by Gambro is a device used for hemodialysis, primarily in patients with renal failure. It is FDA-cleared and supported by limited evidence, with no specific outcomes or safety data reported in the studies provided.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K070643 ↗
Decision Date ?
November 2, 2007
Product Code ?
KDI
Device Class ?
Class 2
Evidence ?
8 studies
The Phoenix Hemodialysis Delivery System was cleared by the FDA through the 510(k) pathway on November 2, 2007. It is manufactured by Gambro and classified as a Class 2 medical device.
What It Is
The Phoenix Hemodialysis Delivery System is a medical device designed to perform hemodialysis, a process that removes waste products and excess fluid from the blood when the kidneys are not functioning properly. It is intended for use in clinical settings to treat patients with renal failure.
FDA-Cleared Indications
- Hemodialysis treatment for patients with renal failure.
- Delivery and monitoring of extracorporeal blood-processing therapy in a clinical dialysis setting.
Clinical Applications
- Hemodialysis for patients with chronic kidney failure.
- Hemodialysis for patients with acute renal failure when dialysis is clinically indicated.
- Removal of metabolic waste products from the blood during dialysis.
- Removal of excess fluid and management of fluid and electrolyte balance during hemodialysis.
Evidence Summary
The available literature includes two studies, though neither provides specific outcomes or safety data related to the Phoenix Hemodialysis Delivery System. The studies are from 2016 and an unspecified date, indicating a need for more recent research.
Reported Outcomes
Published studies report no specific efficacy findings for the Phoenix Hemodialysis Delivery System. The evidence provided does not include detailed outcomes related to its use.
Safety Profile
Reported complications include no specific adverse events or complications as the provided studies do not contain safety data for the Phoenix Hemodialysis Delivery System.
Evidence Limitations
The evidence for the Phoenix Hemodialysis Delivery System is limited, with no detailed outcomes or safety data available from the studies provided. Further research is needed to evaluate its efficacy and safety comprehensively.
Practical Considerations
- Treatment requires vascular access, such as a dialysis catheter, arteriovenous fistula, or arteriovenous graft, along with an extracorporeal blood circuit.
- The system should be operated by trained dialysis personnel according to the manufacturer's instructions and the dialysis prescription.
- The record identifies the product as Version 3 35, but does not provide enough information to confirm specific disposable-set sizes, blood-flow limits, dialysate specifications, or compatibility with other manufacturers' components.
- This is an electrically powered dialysis system and should not be assumed to be MRI safe; it should be kept outside the MRI environment unless the manufacturer has specifically documented MR compatibility.
- Treatment may be contraindicated or require adjustment in patients with unstable blood pressure, active bleeding, inadequate vascular access, severe electrolyte abnormalities, or other conditions identified by the treating nephrology team.
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 are the clinical indications for Phoenix Hemodialysis Delivery System?
The device is indicated for use in hemodialysis to treat patients with renal failure.
What outcomes have been reported in clinical studies?
The studies provided do not report specific outcomes for the Phoenix Hemodialysis Delivery System.
What complications have been reported?
No specific complications have been reported in the studies provided for the Phoenix Hemodialysis Delivery System.
Disclaimer: This page compiles publicly available regulatory and published clinical evidence for educational reference.
It does not constitute medical advice, product endorsement, or a recommendation for clinical use.
Always consult manufacturer documentation and clinical judgment for patient care decisions.