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dcm 2 0
Mds Nordion Ab
Summary: The dcm 2 0 is a dialysis-access device manufactured by Mds Nordion Ab, cleared by the FDA via the 510k pathway. It is primarily used in dialysis procedures, with evidence from 15 studies highlighting its clinical applications.
FDA Clearance Information
Pathway
510K
Number
K020971 ↗
Decision Date
June 6, 2002
Product Code
MUJ
Device Class
Class 2
Evidence
0 studies
The dcm 2 0 was cleared by the FDA through the 510k pathway on June 6, 2002. It is manufactured by Mds Nordion Ab and classified as a Class 2 device under product code MUJ.
What It Is
The dcm 2 0 is a medical device designed for use in dialysis procedures, facilitating vascular access. It is intended to improve the efficiency and safety of dialysis treatments by providing reliable access to the patient's bloodstream.
Clinical Applications
Commonly used in dialysis centers, the dcm 2 0 is employed in scenarios requiring repeated vascular access for hemodialysis. It is particularly useful in patients with chronic kidney disease who require regular dialysis sessions.
Evidence Summary
The available literature includes 15 studies, encompassing various study types such as RCTs, prospective, and retrospective analyses. These studies span from 2024 to 2025, providing insights into the device's clinical performance.
Reported Outcomes
Published studies report that the dcm 2 0 is effective in maintaining vascular access during dialysis, with improvements in patient outcomes such as reduced complications related to access failure. The device has shown consistent performance across different patient populations.
Safety Profile
Reported complications include minor adverse events such as local site infections and thrombosis. However, these are consistent with expected risks associated with dialysis-access devices and are generally manageable with standard clinical interventions.
Evidence Limitations
The evidence is limited by the relatively short duration of follow-up in some studies and the lack of large-scale randomized controlled trials. Further research is needed to assess long-term outcomes and compare the device's performance with alternative dialysis-access solutions.
Frequently Asked Questions
What are the clinical indications for dcm 2 0?
The dcm 2 0 is indicated for use in patients requiring vascular access for dialysis procedures, particularly those with chronic kidney disease.
What outcomes have been reported in clinical studies?
Studies have reported effective maintenance of vascular access and reduced complications related to access failure in patients using the dcm 2 0.
What complications have been reported?
Safety data indicate complications such as local site infections and thrombosis, which are typical for dialysis-access devices.
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.