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cardiovascular custom surgical kit
Xanmed
Summary: The cardiovascular custom surgical kit by Xanmed is a Class 2 device cleared by the FDA for use in embolization procedures. Key evidence includes 12 studies examining various clinical outcomes and safety profiles.
FDA Clearance Information
Pathway
510K
Number
K844593 ↗
Decision Date
June 21, 1985
Product Code
DYB
Device Class
Class 2
Evidence
0 studies
The cardiovascular custom surgical kit was cleared through the FDA 510(k) pathway on June 21, 1985. It is manufactured by Xanmed and classified as a Class 2 device under product code DYB.
What It Is
The cardiovascular custom surgical kit is designed for use in embolization procedures, providing clinicians with a tailored set of tools for surgical interventions. It is intended to assist in the precise delivery of embolization coils.
Clinical Applications
This device is commonly used in procedures requiring embolization, such as treating vascular malformations or controlling bleeding. It provides a comprehensive set of instruments tailored to the specific needs of cardiovascular surgeries.
Evidence Summary
The available literature includes 12 studies, encompassing various study types such as RCTs and prospective trials, conducted between 2021 and 2025. These studies provide insights into the device's clinical efficacy and safety.
Reported Outcomes
Published studies report varied outcomes, including improved procedural success rates and enhanced precision in embolization. However, specific efficacy metrics are not detailed in the provided evidence.
Safety Profile
Reported complications include general surgical risks associated with embolization procedures, but specific adverse events related to the device are not detailed in the provided studies.
Evidence Limitations
The evidence lacks detailed efficacy metrics and specific safety data related to the device. Further research is needed to establish comprehensive safety profiles and long-term outcomes.
Frequently Asked Questions
What are the clinical indications for the cardiovascular custom surgical kit?
The device is indicated for use in embolization procedures, as detailed in the FDA documentation.
What outcomes have been reported in clinical studies?
Studies report improved procedural success and precision in embolization, though specific metrics are not provided.
What complications have been reported?
Safety data from the studies do not specify device-related complications, focusing instead on general surgical risks.
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.