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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
510K
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.
Clinical Applications
This device is frequently used in endovascular procedures, including those involving embolization coils. It is particularly useful in scenarios requiring precise vascular access and manipulation of catheters.
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.
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.