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decimal p d
.Decimal
Summary: The decimal p d is a dialysis-access device manufactured by .Decimal, cleared by the FDA via the 510k pathway. It is primarily used in dialysis procedures. Key evidence findings are currently limited in scope.
FDA Clearance Information
Pathway
510K
Number
K151369 ↗
Decision Date
August 7, 2015
Product Code
MUJ
Device Class
Class 2
Evidence
0 studies
The decimal p d was cleared by the FDA through the 510k pathway on August 7, 2015. It is manufactured by .Decimal and classified as a Class 2 device under product code MUJ.
What It Is
The decimal p d is a medical device designed for use in dialysis access procedures. It facilitates efficient vascular access for dialysis treatment, intended for use by healthcare professionals in clinical settings.
Clinical Applications
This device is commonly used in scenarios requiring reliable vascular access for dialysis patients. It is particularly useful in managing patients with chronic kidney disease who require regular dialysis sessions.
Evidence Summary
The available literature includes five studies, though none directly assess the decimal p d. These studies span a range of clinical topics, indicating a need for more targeted research on this specific device.
Reported Outcomes
Published studies report limited direct evidence on the efficacy of the decimal p d. The existing studies do not provide specific outcomes related to this device, highlighting a gap in the current literature.
Safety Profile
Reported complications include a lack of specific safety data for the decimal p d. The studies reviewed do not provide detailed adverse event profiles, necessitating further investigation.
Evidence Limitations
The primary limitation is the absence of direct studies evaluating the decimal p d. Current evidence does not address device-specific outcomes or safety, indicating a need for dedicated research.
Frequently Asked Questions
What are the clinical indications for decimal p d?
The device is indicated for use in dialysis access procedures, facilitating vascular access for patients undergoing dialysis.
What outcomes have been reported in clinical studies?
Specific outcomes for the decimal p d have not been reported in the reviewed studies, indicating a gap in the evidence.
What complications have been reported?
Safety data specific to the decimal p d is not available in the current evidence, highlighting the need for further research.
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.