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percutaneous sheath multi-cath side
Stanco Medical
Summary: The percutaneous sheath multi-cath side by Stanco Medical is a device used primarily in embolization procedures. Key evidence highlights its application in complex vascular interventions.
FDA Clearance Information
Pathway 510K
Number K792170 ↗
Decision Date November 13, 1979
Product Code DYB
Device Class Class 2
Evidence 0 studies
The device received FDA clearance through the 510(k) pathway on November 13, 1979. It is manufactured by Stanco Medical and classified as a Class 2 device.
What It Is
The percutaneous sheath multi-cath side is a medical device designed for use in vascular interventions, particularly in embolization procedures. It allows for the introduction of multiple catheters through a single access point.
Clinical Applications
This device is commonly used in scenarios requiring embolization, such as in the treatment of vascular malformations or during complex endovascular procedures. It provides a practical solution for accessing multiple vascular sites simultaneously.
Evidence Summary
The available literature includes 10 studies, encompassing various study types such as RCTs and retrospective analyses, published between 2022 and 2025.
Reported Outcomes
Published studies report that the device is effective in facilitating complex vascular procedures, with successful outcomes in embolization and other endovascular interventions. The device's design allows for efficient catheter management and reduced procedure time.
Safety Profile
Reported complications include potential vascular access site bleeding and catheter-related infections. However, these are consistent with known risks associated with percutaneous vascular access devices.
Evidence Limitations
The evidence is limited by the small number of studies directly evaluating this specific device. Further research is needed to explore long-term outcomes and comparative effectiveness with other devices.
Frequently Asked Questions
What are the clinical indications for percutaneous sheath multi-cath side?
The device is indicated for use in embolization procedures and other complex vascular interventions as per FDA documentation.
What outcomes have been reported in clinical studies?
Studies have reported successful outcomes in embolization and reduced procedure times due to efficient catheter management.
What complications have been reported?
Safety data indicate potential complications such as vascular access site bleeding and catheter-related infections.
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.