📊 Evidence-Based Reference
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 ?
510(k)
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.
FDA-Cleared Indications
- Used to introduce catheters or other intravascular devices into a blood vessel.
- Used to provide temporary vascular access during endovascular procedures.
- The specific FDA-cleared indication is defined by the product labeling and may vary by kit configuration, size, and components.
Clinical Applications
- Obtaining arterial or venous access for catheter-based interventions
- Providing access for diagnostic angiography and catheterization
- Providing access for embolization procedures
- Providing radial artery access when the selected kit is labeled for radial access
- Providing access for image-guided vascular procedures
Reported off-label uses
- Use as an access component during procedures outside the device's specific labeling, when selected and used by a qualified clinician
- Use in specialized access techniques described in clinical practice, such as selected gastrostomy access procedures
Off-label use: these uses are reported in practice or the literature but are not part of the FDA-cleared indications. Physicians may use a cleared device off-label based on their medical judgment; the manufacturer may not promote off-label uses.
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.
Practical Considerations
- Select the sheath diameter, usable length, dilator, guidewire, and valve configuration to match the target vessel and catheter system.
- Confirm compatibility with the planned guidewires, catheters, contrast-delivery equipment, and other intravascular devices.
- Insertion is generally performed using a percutaneous technique under ultrasound and fluoroscopic guidance, with local anesthesia and optional moderate sedation.
- Potential complications include bleeding, hematoma, vessel injury, thrombosis, infection, air embolism, and loss of access; use is contraindicated when vascular access is unsafe or clinically inappropriate.
- MRI safety depends on the exact kit and whether any component remains in the patient. Follow the manufacturer's labeling and remove temporary access components before MRI unless their MR status is specifically documented.
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 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.