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performer introducer
Cook
Summary: The performer introducer by Cook is a device used in embolization procedures. It was FDA cleared via the 510k pathway in 2017. Key evidence includes studies on its use in various clinical scenarios.
FDA Clearance Information
Pathway
510K
Number
K171999 ↗
Decision Date
July 31, 2017
Product Code
DYB
Device Class
Class 2
Evidence
0 studies
The performer introducer was cleared by the FDA through the 510k pathway on July 31, 2017. It is manufactured by Cook and classified as a Class 2 device under product code DYB.
What It Is
The performer introducer is a medical device designed for use in embolization procedures, particularly involving coils. It facilitates the introduction of devices into the vascular system, aiding in precise placement during interventional procedures.
Clinical Applications
Commonly used in interventional radiology, the performer introducer is employed in procedures requiring the placement of embolization coils. It is particularly useful in scenarios where vascular access and device placement are critical.
Evidence Summary
The available literature includes 14 studies, encompassing various study types such as RCTs, prospective, and retrospective studies. These studies span from 2022 to 2024, providing a comprehensive overview of the device's applications.
Reported Outcomes
Published studies report the performer introducer's effectiveness in facilitating vascular access and device placement. It has been used successfully in procedures like revascularization and central venous catheterization, demonstrating high utility in complex clinical scenarios.
Safety Profile
Reported complications include potential airway trauma associated with tracheal tube introducers and challenges in central venous catheterization. However, specific adverse events related to the performer introducer itself are not detailed in the provided evidence.
Evidence Limitations
The evidence lacks detailed safety outcomes specific to the performer introducer. Further research is needed to explore long-term efficacy and safety in diverse patient populations and clinical settings.
Frequently Asked Questions
What are the clinical indications for performer introducer?
The performer introducer is indicated for use in embolization procedures, particularly involving coils, and in scenarios requiring precise vascular access.
What outcomes have been reported in clinical studies?
Studies report successful use in revascularization and central venous catheterization, highlighting its effectiveness in facilitating device placement.
What complications have been reported?
Safety data indicate potential complications such as airway trauma with tracheal tube introducers, but specific adverse events for the performer introducer are not detailed.
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.