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cascade hemodialysis apheresis catheter
Health Line International
Summary: The cascade hemodialysis apheresis catheter by Health Line International is a device used primarily for dialysis and apheresis procedures. Key evidence includes studies on its use in rapidly progressive glomerulonephritis and plasmapheresis efficacy.
FDA Clearance Information
Pathway
510K
Number
K130851 ↗
Decision Date
January 9, 2014
Product Code
MSD
Device Class
Class 2
Evidence
0 studies
The cascade hemodialysis apheresis catheter was cleared by the FDA via the 510(k) pathway on January 9, 2014. It is manufactured by Health Line International and classified as a Class 2 device.
What It Is
The cascade hemodialysis apheresis catheter is designed for use in dialysis and apheresis procedures. It facilitates the removal and filtration of blood components, intended for patients requiring extracorporeal blood purification.
Clinical Applications
Commonly used in scenarios requiring dialysis access, the catheter is applicable in treatments such as plasmapheresis and hemodialysis, particularly in patients with compromised renal function or specific blood disorders.
Evidence Summary
The available literature includes two studies: one from 1995 on rapidly progressive glomerulonephritis treated with apheresis, and another evaluating plasmapheresis efficacy. These studies provide insights into the device's clinical applications and outcomes.
Reported Outcomes
Published studies report that the device has been used effectively in treating rapidly progressive glomerulonephritis and in plasmapheresis procedures. The outcomes indicate potential benefits in renal survival and filtration efficiency.
Safety Profile
Reported complications include the general risks associated with central venous catheterization, such as infection and thrombosis. Specific safety data from the studies are limited.
Evidence Limitations
The evidence is limited by the small number of studies and the lack of recent data. Further research is needed to evaluate long-term outcomes and safety in diverse patient populations.
Frequently Asked Questions
What are the clinical indications for cascade hemodialysis apheresis catheter?
The device is indicated for use in dialysis and apheresis procedures, particularly in patients with renal impairment or requiring blood component filtration.
What outcomes have been reported in clinical studies?
Studies have reported effective use in rapidly progressive glomerulonephritis and plasmapheresis, with potential benefits in renal survival.
What complications have been reported?
Safety data indicate risks such as infection and thrombosis, common to central venous catheterization.
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.