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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. Cleared by FDA via 510k. Key evidence includes improved techniques for radial artery access.
FDA Clearance Information
Pathway
510K
Number
K222184 ↗
Decision Date
February 21, 2023
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 February 21, 2023. They are classified as Class 2 devices under product code DYB.
What It Is
Introducer sheath kits are medical devices used to facilitate the insertion of catheters into blood vessels during endovascular procedures. They are designed to provide a stable and less traumatic access point for catheterization.
Clinical Applications
These devices are commonly used in procedures requiring vascular access, such as embolization and other endovascular interventions. They are particularly useful in scenarios where radial artery access is needed.
Evidence Summary
The available literature includes three studies, with publication years ranging from 2000 to 2006. The studies encompass various methodologies, including RCTs and prospective analyses, focusing on techniques and cost-effectiveness.
Reported Outcomes
Published studies report improved techniques for radial artery access using introducer sheath kits, highlighting their flexibility and reduced trauma compared to traditional methods. Cost reduction in PEG procedures was also noted.
Safety Profile
Reported complications include potential difficulties in guide wire advancement, which can be mitigated by using more flexible catheters. No significant adverse events were highlighted in the provided studies.
Evidence Limitations
The evidence is limited by the age of the studies and the lack of large-scale, recent trials. Further research is needed to confirm long-term safety and efficacy in diverse clinical settings.
Frequently Asked Questions
What are the clinical indications for introducer sheath kits?
Introducer sheath kits are indicated for use in endovascular interventions requiring vascular access, such as embolization procedures.
What outcomes have been reported in clinical studies?
Studies have reported improved techniques for radial artery access and cost reduction in PEG procedures.
What complications have been reported?
Reported complications include difficulties in guide wire advancement, which can be addressed by using more flexible catheters.
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.