đź“Š Evidence-Based Reference
prelude
Medcom
Summary: Prelude is a dialysis-access device by Medcom, primarily used to facilitate vascular access in dialysis patients. Cleared by FDA via 510k pathway, it is supported by 15 studies, though specific outcomes and safety data are limited.
FDA Clearance Information
Pathway
510K
Number
K180308 ↗
Decision Date
March 27, 2018
Product Code
MUJ
Device Class
Class 2
Evidence
0 studies
The Prelude device was cleared by the FDA through the 510k pathway on March 27, 2018. Manufactured by Medcom, it is classified as a Class 2 medical device.
What It Is
Prelude is a medical device designed to assist in creating and maintaining vascular access for dialysis patients. It is intended for use in clinical settings to improve the efficiency and safety of dialysis procedures.
Clinical Applications
Commonly used in dialysis centers, Prelude is employed in scenarios requiring reliable vascular access. It is particularly useful for patients undergoing regular dialysis treatments.
Evidence Summary
The available literature includes 15 studies, with a mix of study types such as RCTs and case series. The studies span from 1995 to 2025, though specific details on outcomes and safety are sparse.
Reported Outcomes
Published studies report limited specific outcomes for the Prelude device. While the device is generally used to facilitate dialysis access, detailed efficacy findings are not extensively documented in the provided evidence.
Safety Profile
Reported complications include general risks associated with vascular access devices, though specific adverse events related to Prelude are not detailed in the available studies.
Evidence Limitations
The evidence base for Prelude is limited by a lack of detailed outcome and safety data. Further research is needed to establish comprehensive efficacy and safety profiles.
Frequently Asked Questions
What are the clinical indications for Prelude?
Prelude is indicated for use in creating and maintaining vascular access for dialysis patients.
What outcomes have been reported in clinical studies?
Specific outcomes for Prelude are not extensively documented in the available studies.
What complications have been reported?
Safety data specific to Prelude is limited, with general risks associated with vascular access devices noted.
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.