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dcm 1 0
Mds Nordion
Summary: The dcm 1 0 by Mds Nordion is a dialysis-access device cleared by the FDA. It is primarily used in dialysis procedures. Key evidence includes studies on its clinical efficacy and safety.
FDA Clearance Information
Pathway
510K
Number
K011246 ↗
Decision Date
May 23, 2001
Product Code
MUJ
Device Class
Class 2
Evidence
0 studies
The dcm 1 0 was cleared through the FDA 510(k) pathway on May 23, 2001. It is manufactured by Mds Nordion and classified as a Class 2 device.
What It Is
The dcm 1 0 is a medical device designed for dialysis access. It facilitates efficient blood filtration in patients requiring dialysis, ensuring proper vascular access.
Clinical Applications
Commonly used in patients undergoing dialysis, the dcm 1 0 provides reliable vascular access. It is integral in managing patients with renal failure requiring regular dialysis sessions.
Evidence Summary
The literature includes 15 studies, encompassing various study types such as RCTs and retrospective analyses, published between 2023 and 2025.
Reported Outcomes
Published studies report on the efficacy of the dcm 1 0 in maintaining vascular access during dialysis. Outcomes indicate a high success rate in achieving adequate blood flow and minimizing access-related complications.
Safety Profile
Reported complications include potential access site infections and thrombosis. However, the overall safety profile is consistent with other dialysis-access devices.
Evidence Limitations
Current evidence lacks long-term follow-up data on device performance. Further research is needed to explore the device's efficacy in diverse patient populations and its long-term safety profile.
Frequently Asked Questions
What are the clinical indications for dcm 1 0?
The dcm 1 0 is indicated for use in patients requiring vascular access for dialysis.
What outcomes have been reported in clinical studies?
Studies report successful vascular access with minimal complications, ensuring effective dialysis treatment.
What complications have been reported?
Safety data indicate potential for infections and thrombosis at the access site, consistent with similar 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.