đź“Š Evidence-Based Reference
micropuncture introducer set micropuncture introducer set with push-plus design micropuncture introducer set with silhouette transitionless design micropuncture introducer set with silhouette transitionless design and push-plus design
Cook
Summary: The micropuncture introducer set by Cook is a device used for vascular access, particularly in endovascular procedures. Key evidence highlights its use in complex aortic repairs and embolization procedures.
FDA Clearance Information
Pathway
510K
Number
K171275 ↗
Decision Date
December 20, 2017
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 December 20, 2017. It is manufactured by Cook and classified as a Class 2 device.
What It Is
The micropuncture introducer set is designed for vascular access, featuring a transitionless design for smooth insertion. It is intended for use in procedures requiring precise vascular entry, such as endovascular interventions.
Clinical Applications
Commonly used in endovascular procedures, the micropuncture introducer set facilitates access to the vascular system. It is particularly useful in complex aortic repairs and embolization procedures, providing reliable entry for subsequent interventions.
Evidence Summary
The available literature includes 9 studies, ranging from case series to prospective trials, published between 2015 and 2025. These studies explore the device's application in various vascular procedures.
Reported Outcomes
Published studies report successful use of the micropuncture introducer set in complex endovascular aortic repairs and embolization of type 2 endoleaks. The device has been shown to facilitate precise vascular access, contributing to procedural success.
Safety Profile
Reported complications include challenges related to the proximity of puncture sites in embolization procedures. However, no significant adverse events directly attributed to the device were noted in the reviewed studies.
Evidence Limitations
The evidence is limited by the small number of studies and the lack of large-scale randomized controlled trials. Further research is needed to fully understand the long-term safety and efficacy of the device across diverse patient populations.
Frequently Asked Questions
What are the clinical indications for the micropuncture introducer set?
The micropuncture introducer set is indicated for vascular access in endovascular procedures, including complex aortic repairs and embolization.
What outcomes have been reported in clinical studies?
Studies report successful vascular access and procedural success in complex aortic repairs and embolization using the micropuncture introducer set.
What complications have been reported?
Reported complications include challenges with puncture site proximity in embolization, but no significant adverse events directly linked to the device.
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.