đź“‹ FDA Reference
transonic hemodialysis flow reverser model b flowrev
Transonic Systems
Summary: The Transonic Hemodialysis Flow Reverser Model B FlowRev is a medical device used to optimize blood flow during hemodialysis. It is primarily used by nephrologists and dialysis technicians to enhance dialysis efficiency and patient outcomes.
FDA Clearance Information
Pathway
510K
Number
K002816 ↗
Decision Date
November 22, 2000
Product Code
KOC
Device Class
Class 2
Evidence
0 studies
The Transonic Hemodialysis Flow Reverser Model B FlowRev was cleared through the FDA 510(k) pathway on November 22, 2000. It is manufactured by Transonic Systems and classified as a Class 2 device under product code KOC.
What It Is
The Transonic Hemodialysis Flow Reverser Model B FlowRev is designed to reverse the direction of blood flow during hemodialysis sessions. This device helps in optimizing the efficiency of dialysis by ensuring better clearance of toxins from the blood. It is particularly useful in cases where traditional blood flow patterns are insufficient for effective dialysis.
Clinical Applications
This device is commonly used in dialysis centers and hospitals where hemodialysis is performed. Nephrologists and dialysis technicians use it to manage patients with chronic kidney disease requiring dialysis. It is particularly beneficial in patients with compromised vascular access or those experiencing inadequate dialysis clearance.
Indications for Use
The FDA-cleared indications for this device include use in patients undergoing hemodialysis who require optimized blood flow to improve dialysis efficiency. It is indicated for patients with chronic kidney disease where standard dialysis techniques are insufficient.
Practical Considerations
The device is compatible with standard hemodialysis machines and can be easily integrated into existing dialysis setups. Clinicians should ensure proper sizing and compatibility with the patient's vascular access to maximize the device's effectiveness.
Frequently Asked Questions
What is the Transonic Hemodialysis Flow Reverser Model B FlowRev used for?
It is used to reverse blood flow direction during hemodialysis to improve dialysis efficiency and patient outcomes.
What specialties typically use this device?
Nephrologists and dialysis technicians commonly use this device in dialysis centers and hospital settings.
What are the FDA-cleared indications?
The device is indicated for use in hemodialysis patients requiring optimized blood flow for improved dialysis efficiency, particularly in those with compromised vascular access.
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.