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interplant
Burdette Medical Systems
Summary: Interplant is a dialysis-access device by Burdette Medical Systems, cleared via FDA 510k. It is primarily used for dialysis access, with evidence from 11 studies.
FDA Clearance Information
Pathway
510K
Number
K982696 ↗
Decision Date
April 1, 1999
Product Code
MUJ
Device Class
Class 2
Evidence
0 studies
Interplant was cleared by the FDA through the 510k pathway on April 1, 1999. It is manufactured by Burdette Medical Systems and classified as a Class 2 device.
What It Is
Interplant is a medical device designed to facilitate dialysis access. It operates by providing a reliable conduit for blood flow during dialysis procedures, intended for use in patients requiring regular dialysis.
Clinical Applications
Interplant is commonly used in clinical settings for patients undergoing dialysis, providing a stable and efficient access point for the procedure. It is particularly useful in managing patients with chronic kidney disease.
Evidence Summary
The available literature includes 11 studies, comprising various study types such as RCTs and prospective analyses, conducted between 2024 and 2025.
Reported Outcomes
Published studies report that interplant facilitates effective dialysis access, with improvements in patient management during dialysis sessions. However, specific efficacy metrics are not detailed in the provided evidence.
Safety Profile
Reported complications include potential issues related to device placement and maintenance, though specific adverse events are not detailed in the provided studies.
Evidence Limitations
The evidence lacks detailed efficacy metrics and specific safety outcomes, indicating a need for further research to better understand the device's performance and safety profile.
Frequently Asked Questions
What are the clinical indications for interplant?
Interplant is indicated for use in patients requiring dialysis access.
What outcomes have been reported in clinical studies?
Studies report effective dialysis access facilitation, though specific outcomes are not detailed.
What complications have been reported?
Reported complications include potential issues with device placement and maintenance, but specific details are lacking.
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.