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allient sorbent hemodialysis system model 1500

Renal Solutions

Summary: The Allient Sorbent Hemodialysis System Model 1500 is a portable dialysis device used for patients requiring hemodialysis. It is primarily used by nephrologists in clinical settings.

FDA Clearance Information

Pathway 510K
Decision Date May 25, 2007
Product Code FKT
Device Class Class 2
Evidence 0 studies

The Allient Sorbent Hemodialysis System Model 1500, manufactured by Renal Solutions, was cleared by the FDA under 510k K070739 on May 25, 2007. It is classified as a Class 2 device.

What It Is

The Allient Sorbent Hemodialysis System Model 1500 is a medical device designed for hemodialysis, utilizing sorbent technology to filter waste products from the blood. This system is particularly advantageous in settings where water supply is limited, as it does not require a continuous water source. The device uses a sorbent cartridge to regenerate dialysate, making it suitable for portable applications.

Clinical Applications

This device is commonly used in nephrology for patients with end-stage renal disease or acute kidney injury requiring dialysis. It is particularly useful in outpatient dialysis centers, home dialysis settings, and in situations where traditional dialysis infrastructure is unavailable, such as during natural disasters or in remote locations. The portability of the system makes it suitable for patients who require flexible dialysis options.

Indications for Use

The FDA-cleared indications for this device include use in patients who require hemodialysis due to kidney failure. It is intended for individuals who need regular dialysis treatments to remove waste products from their blood.

Practical Considerations

The Allient Sorbent Hemodialysis System is designed to be compact and portable, making it suitable for use in various settings. Clinicians should be aware of its compatibility with sorbent cartridges and the need for proper anticoagulation management, especially when using citrate.

Related Literature

The linked study investigated the use of a Selective Cytopheretic Inhibitory Device (SCD) with regional citrate anticoagulation in conjunction with a portable sorbent dialysis system. The study highlighted the potential of this combination for immunomodulatory therapy in severe sepsis and acute kidney injury. However, the interaction between citrate and sorbent dialysis poses challenges, particularly in portable systems. The study suggests potential applications in challenging environments like battlefields or disaster zones.

Frequently Asked Questions

What is the Allient Sorbent Hemodialysis System used for?

It is used for providing hemodialysis to patients with kidney failure, especially in settings where traditional dialysis infrastructure is unavailable.

What specialties typically use this device?

Nephrologists and other healthcare providers specializing in renal care typically use this device.

What are the FDA-cleared indications?

The device is indicated for patients requiring hemodialysis due to kidney failure.

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.

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