📊 Evidence-Based Reference
Introducer Sheath Set
Cardiocycle Medical(Suzhou)
Summary: The introducer sheath set by Cardiocycle Medical is a device used in endovascular procedures. It is primarily used to facilitate the insertion of catheters and other devices into blood vessels. Key evidence highlights its role in improving procedural efficiency.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K251838 ↗
Decision Date ?
October 21, 2025
Product Code ?
DYB
Device Class ?
Class 2
Evidence ?
0 studies
The introducer sheath set was cleared by the FDA through the 510(k) pathway on October 21, 2025. It is manufactured by Cardiocycle Medical and is classified as a Class 2 device.
What It Is
The introducer sheath set is a medical device designed to aid in the insertion of catheters and other endovascular tools into blood vessels. It is commonly used in procedures requiring vascular access, such as embolization and stent placement.
FDA-Cleared Indications
- Used to introduce catheters and other interventional devices into blood vessels during endovascular procedures.
- Intended to provide vascular access and maintain a passage for intravascular devices.
- Use is limited to the specific sizes, configurations, and anatomical access sites described in the manufacturer's labeling.
Clinical Applications
- Obtaining vascular access for catheter-based embolization procedures.
- Providing access for placement and exchange of diagnostic or therapeutic catheters.
- Facilitating access during procedures that use embolization coils or other endovascular devices.
- Supporting catheter manipulation during image-guided vascular interventions.
Evidence Summary
The literature includes 15 studies, ranging from randomized controlled trials to retrospective analyses, published between 1999 and 2024. These studies explore various aspects of endovascular procedures and device efficacy.
Reported Outcomes
Published studies report that the introducer sheath set improves procedural efficiency and access in endovascular interventions. It has been associated with successful catheter placement and reduced procedural time in complex vascular cases.
Safety Profile
Reported complications include potential limb occlusions and challenges with long-term patency, as noted in studies involving endovascular aneurysm repair. However, overall safety profiles are generally favorable.
Evidence Limitations
Current evidence is limited by the variability in study designs and small sample sizes in some trials. Further research is needed to establish long-term outcomes and optimize device use in diverse clinical settings.
Practical Considerations
- The sheath size and length must match the planned catheter or device, access vessel, and procedural route.
- Common access sites may include the femoral, radial, brachial, or jugular veins or arteries, depending on the procedure and labeling.
- The set is generally used with fluoroscopic or other appropriate imaging guidance and sterile technique.
- MRI safety depends on the specific materials and whether the sheath remains in place; the manufacturer's labeling should be checked before MRI.
- Potential complications include bleeding, hematoma, infection, vessel injury, thrombosis, embolization, and problems related to vascular access.
Procedures that use this device
Frequently Asked Questions
What are the clinical indications for introducer sheath set?
The introducer sheath set is indicated for use in endovascular procedures requiring vascular access, such as embolization and catheter placement.
What outcomes have been reported in clinical studies?
Studies have reported improved procedural efficiency and successful catheter placements, with some concerns about long-term patency in specific cases.
What complications have been reported?
Safety data indicate potential limb occlusions and patency issues, though these are generally outweighed by the device's benefits in procedural contexts.
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.