📊 Evidence-Based Reference
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 ?
510(k)
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.
FDA-Cleared Indications
- Used to provide vascular access for the introduction of catheters and other intravascular devices.
- Intended for use during endovascular procedures requiring catheter access to the vasculature.
Clinical Applications
- Establishing access for diagnostic or therapeutic endovascular catheter procedures.
- Providing a stable access pathway during embolization procedures.
- Providing radial artery access when an endovascular procedure is performed through the wrist.
- Supporting catheter introduction and exchange during image-guided vascular interventions.
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.
Practical Considerations
- Choose the sheath diameter and length based on the access vessel, catheter or device compatibility, and the planned procedure.
- Confirm that the sheath's inner diameter accommodates the intended catheter or device and that all components are compatible before use.
- Common access sites include the radial, femoral, and other peripheral arteries or veins, depending on the procedure.
- Insertion is generally performed using sterile technique and imaging guidance, with local anesthesia and optional moderate sedation.
- MRI safety depends on the specific kit and its components. The device labeling should be checked before MRI; a sheath left in the body should not be assumed to be MRI safe.
Procedures that use this device
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.