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introducer sheath kits
Beijing Demax Medical Technology
Summary: Introducer sheath kits by Beijing Demax Medical Technology are used in endovascular interventions. FDA 510k cleared, with studies highlighting their application in radial artery access and cost-effective gastrostomy techniques.
FDA Clearance Information
Pathway
510K
Number
K242248 ↗
Decision Date
August 22, 2024
Product Code
DYB
Device Class
Class 2
Evidence
0 studies
The introducer sheath kits by Beijing Demax Medical Technology received FDA clearance through the 510k pathway on August 22, 2024. They are classified as Class 2 devices.
What It Is
Introducer sheath kits are medical devices used to facilitate the insertion of catheters into blood vessels. They are designed to provide a stable and safe access point for various endovascular procedures.
Clinical Applications
These kits are commonly used in procedures requiring vascular access, such as embolization and catheterization. They are particularly useful in interventions involving the radial artery and in cost-effective gastrostomy techniques.
Evidence Summary
The literature includes a mix of study types, such as RCTs and case series, with evidence spanning from 2000 to 2006. The studies focus on techniques for vascular access and cost reduction in gastrostomy procedures.
Reported Outcomes
Published studies report improved techniques for radial artery access and cost-effective methods for gastrostomy. The use of flexible catheters has been associated with reduced trauma and enhanced procedural efficiency.
Safety Profile
Reported complications include potential difficulties in guide wire advancement and the need for alternative techniques to minimize trauma. No specific adverse events were detailed in the provided studies.
Evidence Limitations
The evidence is limited by the small number of studies and the lack of recent data. Further research is needed to explore long-term outcomes and broader clinical applications.
Frequently Asked Questions
What are the clinical indications for introducer sheath kits?
Introducer sheath kits are indicated for use in endovascular procedures requiring vascular access, such as embolization and catheterization.
What outcomes have been reported in clinical studies?
Studies have reported improved techniques for radial artery access and cost-effective gastrostomy methods, with reduced procedural trauma.
What complications have been reported?
Reported complications include difficulties in guide wire advancement and the need for alternative techniques to minimize trauma.
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.