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Konrad Model V 2 0
Mrc Systems
Summary: The Konrad Model V 2 0 by Mrc Systems is a dialysis-access device cleared by the FDA. It is primarily used in dialysis procedures. Current evidence lacks specific outcomes and safety data.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K022307 ↗
Decision Date ?
October 8, 2002
Product Code ?
MUJ
Device Class ?
Class 2
Evidence ?
0 studies
The Konrad Model V 2 0 was cleared by the FDA through the 510(k) pathway on October 8, 2002. It is manufactured by Mrc Systems and classified as a Class 2 device under product code MUJ.
What It Is
The Konrad Model V 2 0 is a medical device designed for use in dialysis procedures. It facilitates access to the vascular system, which is crucial for effective dialysis treatment.
FDA-Cleared Indications
- Use in dialysis-related vascular access procedures, based on the available FDA record and product code classification.
Clinical Applications
- Vascular access procedures for patients receiving dialysis
- Establishing access to the vascular system for dialysis treatment
- Maintaining vascular access during dialysis care
Evidence Summary
The available literature includes three studies, although none provide specific data on outcomes or safety related to the Konrad Model V 2 0. The studies are registered on ClinicalTrials.gov but lack detailed findings.
Reported Outcomes
Published studies report no specific efficacy findings for the Konrad Model V 2 0. The linked studies do not provide detailed outcomes related to the device's performance in clinical settings.
Safety Profile
Reported complications include no specific adverse events related to the Konrad Model V 2 0, as the linked studies do not provide safety data for this device.
Evidence Limitations
The evidence for the Konrad Model V 2 0 is limited, with no specific data on clinical outcomes or safety. Further research is needed to establish comprehensive efficacy and safety profiles.
Practical Considerations
- The available record does not identify the device's dimensions, catheter or access configuration, or compatibility requirements.
- Confirm the specific instructions for use, vessel size requirements, and compatible equipment before use.
- MRI safety information is not provided in the available FDA summary; verify MR Safe, MR Conditional, or MR Unsafe labeling with the manufacturer.
- Use should follow the device labeling and standard dialysis-access protocols, with assessment for infection, thrombosis, bleeding, and vessel suitability.
- The FDA record does not provide a defined service life or replacement interval.
Frequently Asked Questions
What are the clinical indications for Konrad Model V 2 0?
The device is indicated for use in dialysis procedures to facilitate vascular access.
What outcomes have been reported in clinical studies?
No specific outcomes have been reported in the available studies for this device.
What complications have been reported?
The available evidence does not report specific complications for the Konrad Model V 2 0.
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.