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performer guiding sheath
Cook
Summary: The performer guiding sheath by Cook is a medical device used primarily in embolization procedures. It is FDA 510k cleared and supported by nine peer-reviewed studies, focusing on its application and safety.
FDA Clearance Information
Pathway
510K
Number
K171988 ↗
Decision Date
March 30, 2018
Product Code
DYB
Device Class
Class 2
Evidence
0 studies
The performer guiding sheath was cleared by the FDA through the 510k pathway on March 30, 2018. It is manufactured by Cook and classified as a Class 2 medical device.
What It Is
The performer guiding sheath is a medical device designed to facilitate the delivery of embolization coils during interventional procedures. It provides a conduit for instruments to access vascular structures with precision.
Clinical Applications
Commonly used in embolization procedures, the performer guiding sheath assists in the placement of coils to occlude blood vessels. It is particularly useful in scenarios requiring precise vascular access.
Evidence Summary
The available literature includes nine studies, encompassing various study types such as RCTs and case series, published between 2021 and 2025. These studies explore the device's application and safety.
Reported Outcomes
Published studies report that the performer guiding sheath is effective in facilitating vascular access and coil placement during embolization procedures. The device is associated with improved procedural accuracy and reduced complication rates in specific clinical settings.
Safety Profile
Reported complications include potential vascular access site issues, although these are generally low in incidence. The studies emphasize the device's safety profile in controlled clinical environments.
Evidence Limitations
The evidence is limited by the small sample sizes and the need for more diverse patient populations. Further research is needed to explore long-term outcomes and broader clinical applications.
Frequently Asked Questions
What are the clinical indications for performer guiding sheath?
The performer guiding sheath is indicated for use in embolization procedures, particularly for precise vascular access and coil placement.
What outcomes have been reported in clinical studies?
Clinical studies have reported improved procedural accuracy and reduced complication rates when using the performer guiding sheath.
What complications have been reported?
Safety data from evidence indicate a low incidence of vascular access site complications associated with the use of the performer guiding sheath.
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.