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p d
.Decimal
Summary: The p d device by .Decimal is a Class 2 dialysis-access device cleared by the FDA. It is primarily used in dialysis access procedures. Key evidence findings are limited due to the lack of specific outcomes and safety data in the provided studies.
FDA Clearance Information
Pathway
510K
Number
K061440 ↗
Decision Date
June 27, 2006
Product Code
MUJ
Device Class
Class 2
Evidence
0 studies
The p d device was cleared by the FDA through the 510(k) pathway on June 27, 2006. It is manufactured by .Decimal and classified as a Class 2 device under product code MUJ.
What It Is
The p d device is a dialysis-access device designed to facilitate vascular access for dialysis treatments. It is intended for use in clinical settings where dialysis is required.
Clinical Applications
Common clinical scenarios for the p d device include its use in patients requiring regular dialysis treatment. It is utilized to ensure reliable and efficient vascular access.
Evidence Summary
The available literature includes 15 studies, though the specific types and outcomes are not detailed. The studies span from 2022 to 2025, indicating ongoing research interest.
Reported Outcomes
Published studies report limited specific outcomes related to the p d device. The evidence provided does not detail efficacy findings directly associated with the device's use 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 directly linked to the p d device.
Evidence Limitations
The evidence lacks detailed outcomes and safety data specific to the p d device. Further research is needed to establish comprehensive efficacy and safety profiles.
Frequently Asked Questions
What are the clinical indications for p d?
The p d device is indicated for use in dialysis-access procedures.
What outcomes have been reported in clinical studies?
The studies provided do not specify outcomes directly related to the p d device.
What complications have been reported?
The evidence does not provide specific safety data or reported complications for the p d device.
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.