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micropuncture introducer set
Cook
Summary: The micropuncture introducer set by Cook is a device used primarily for vascular access in endovascular procedures. Key evidence highlights its role in embolization and complex aortic repairs.
FDA Clearance Information
Pathway
510K
Number
K133114 ↗
Decision Date
July 3, 2014
Product Code
DYB
Device Class
Class 2
Evidence
0 studies
The micropuncture introducer set was cleared by the FDA via the 510(k) pathway on July 3, 2014. It is manufactured by Cook and classified as a Class 2 device.
What It Is
The micropuncture introducer set is designed for percutaneous vascular access, facilitating the introduction of guidewires and catheters. It is commonly used in endovascular procedures to ensure precise and minimally invasive access.
Clinical Applications
This device is frequently used in procedures such as embolization and aortic repairs, where precise vascular access is critical. It is particularly useful in challenging anatomical scenarios requiring delicate manipulation.
Evidence Summary
The literature includes 9 studies, ranging from case series to retrospective analyses, published between 2015 and 2025. These studies explore various clinical applications and outcomes of the device.
Reported Outcomes
Published studies report successful use of the micropuncture introducer set in embolization procedures and complex aortic repairs. The device has been shown to facilitate effective vascular access, contributing to positive procedural outcomes.
Safety Profile
Reported complications include challenges in achieving hemostasis and potential vascular injury. However, these are generally manageable with appropriate technique and device handling.
Evidence Limitations
The evidence is limited by the small sample sizes and the retrospective nature of some studies. Further research is needed to establish long-term outcomes and safety in diverse patient populations.
Frequently Asked Questions
What are the clinical indications for micropuncture introducer set?
The device is indicated for vascular access in endovascular procedures, such as embolization and aortic repairs.
What outcomes have been reported in clinical studies?
Studies have reported successful vascular access and positive procedural outcomes in embolization and aortic repair cases.
What complications have been reported?
Safety data indicate potential complications such as difficulties in hemostasis and vascular injury, which are generally manageable.
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.