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dimesol tubing sets for hemodialysis
Dimesol
Summary: Dimesol tubing sets are used in hemodialysis to facilitate blood filtration. Cleared by FDA via 510k pathway. Key evidence highlights potential hypersensitivity reactions linked to sterilization methods.
FDA Clearance Information
Pathway
510K
Number
K171952 ↗
Decision Date
March 30, 2018
Product Code
FJK
Device Class
Class 2
Evidence
0 studies
The Dimesol tubing sets for hemodialysis were cleared by the FDA through the 510k pathway on March 30, 2018. Manufactured by Dimesol, these devices are classified as Class 2 under product code FJK.
What It Is
Dimesol tubing sets are medical devices used in hemodialysis to connect the patient's blood circulation to the dialysis machine. They are designed to withstand the pressures and flows typical in hemodialysis procedures, ensuring safe and effective blood filtration.
Clinical Applications
These tubing sets are commonly used in clinical settings for patients undergoing hemodialysis, particularly those with end-stage renal disease. They are essential components in the dialysis process, facilitating the removal of waste products from the blood.
Evidence Summary
The available literature includes 10 studies, comprising various study types such as RCTs, case series, and retrospective analyses, published between 2021 and 2023. These studies explore both the efficacy and safety of hemodialysis tubing sets.
Reported Outcomes
Published studies report that Dimesol tubing sets effectively facilitate hemodialysis, with outcomes focusing on the successful removal of waste products from the blood. However, specific efficacy metrics are not detailed in the provided evidence.
Safety Profile
Reported complications include hypersensitivity reactions potentially linked to ethylene oxide sterilization, as noted in a study on apheresis sets. Other safety concerns are not explicitly detailed in the provided evidence.
Evidence Limitations
The evidence lacks detailed efficacy metrics and comprehensive safety data specific to Dimesol tubing sets. Further research is needed to explore long-term outcomes and compare sterilization methods.
Frequently Asked Questions
What are the clinical indications for Dimesol tubing sets for hemodialysis?
Dimesol tubing sets are indicated for use in hemodialysis procedures to facilitate blood filtration in patients with renal failure.
What outcomes have been reported in clinical studies?
Studies report effective facilitation of hemodialysis, though specific efficacy metrics are not detailed.
What complications have been reported?
Safety data indicate potential hypersensitivity reactions linked to ethylene oxide sterilization.
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.