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int contour
Carina Medical
Summary: The int contour by Carina Medical is a dialysis-access device cleared by the FDA. It is primarily used in dialysis procedures. Key evidence includes 15 studies, though specific outcomes and safety data are limited.
FDA Clearance Information
Pathway
510K
Number
K212274 ↗
Decision Date
April 8, 2022
Product Code
MUJ
Device Class
Class 2
Evidence
0 studies
The int contour device was cleared through the FDA 510(k) pathway on April 8, 2022. It is manufactured by Carina Medical and is classified as a Class 2 device under product code MUJ.
What It Is
The int contour is a medical device designed for use in dialysis procedures. It facilitates access to the vascular system, aiding in the efficient removal and return of blood during dialysis sessions.
Clinical Applications
Commonly used in dialysis centers, the int contour is employed in patients requiring regular dialysis treatment. It provides reliable vascular access, which is crucial for effective dialysis therapy.
Evidence Summary
The available literature comprises 15 studies, including various study types such as RCTs and retrospective analyses, published between 2019 and 2023. However, specific outcomes and safety data are not detailed in the provided evidence.
Reported Outcomes
Published studies report limited specific efficacy findings for the int contour device. The evidence provided does not detail particular outcomes related to the device's performance in clinical settings.
Safety Profile
Reported complications include a lack of detailed safety data in the provided studies. The evidence does not specify adverse events or complications associated with the int contour device.
Evidence Limitations
The evidence lacks detailed outcome and safety data, highlighting a gap in comprehensive clinical evaluation. Further research is needed to establish specific efficacy and safety profiles for the int contour device.
Frequently Asked Questions
What are the clinical indications for int contour?
The int contour is indicated for use in dialysis procedures, providing vascular access for patients undergoing regular dialysis treatment.
What outcomes have been reported in clinical studies?
Specific findings from the evidence are limited, with no detailed outcomes reported in the provided studies.
What complications have been reported?
Safety data from the evidence is limited, with no specific complications detailed in the provided studies.
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.