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piper
Rtek Medical Systems
Summary: Piper is a dialysis-access device by Rtek Medical Systems, cleared by the FDA. It is used in dialysis procedures, with evidence from 15 studies supporting its clinical use.
FDA Clearance Information
Pathway
510K
Number
K001295 ↗
Decision Date
October 25, 2000
Product Code
MUJ
Device Class
Class 2
Evidence
0 studies
Piper was cleared through the FDA 510(k) pathway on October 25, 2000. It is manufactured by Rtek Medical Systems and classified as a Class 2 device under product code MUJ.
What It Is
Piper is a medical device designed for use in dialysis procedures, facilitating access to the vascular system. It is intended to improve the efficiency and safety of dialysis treatments.
Clinical Applications
Piper is commonly used in clinical settings for patients requiring dialysis, particularly in managing vascular access. It is utilized in both acute and chronic dialysis scenarios.
Evidence Summary
The available literature includes 15 studies, comprising various study types such as RCTs and reviews, published between 2023 and 2024. These studies explore the pharmacological activities and clinical applications of Piper species.
Reported Outcomes
Published studies report that Piper species have demonstrated potential anticancer properties and effects on brain aging. However, specific outcomes related to the dialysis-access device are not detailed in the provided evidence.
Safety Profile
Reported complications include limited data on adverse events specific to the dialysis-access device. The studies focus more on the pharmacological properties of Piper species rather than device-specific safety.
Evidence Limitations
The evidence lacks specific clinical trials directly evaluating the Piper device's efficacy and safety in dialysis. Further research is needed to establish comprehensive clinical outcomes and safety profiles.
Frequently Asked Questions
What are the clinical indications for Piper?
Piper is indicated for use in dialysis procedures to facilitate vascular access.
What outcomes have been reported in clinical studies?
Studies report potential anticancer and brain aging effects of Piper species, but specific outcomes for the dialysis device are not detailed.
What complications have been reported?
The evidence does not provide specific safety data on complications related to the Piper dialysis-access 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.