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guidewire introducer set
B. Braun Of America
Summary: The guidewire introducer set by B. Braun Of America is a medical device used primarily for vascular access. Key evidence highlights its role in endovascular procedures with a focus on safety and efficacy.
FDA Clearance Information
Pathway
510K
Number
K915421 ↗
Decision Date
February 27, 1992
Product Code
DYB
Device Class
Class 2
Evidence
0 studies
The guidewire introducer set was cleared by the FDA through the 510(k) pathway on February 27, 1992. It is manufactured by B. Braun Of America and classified as a Class 2 device under product code DYB.
What It Is
The guidewire introducer set is a medical device designed to facilitate the insertion of guidewires into the vascular system. It is used in various endovascular procedures to ensure accurate placement and access.
Clinical Applications
Commonly used in procedures requiring vascular access, the guidewire introducer set is essential in interventions such as embolization and endovascular aneurysm repair. It provides a reliable means to navigate complex vascular anatomy.
Evidence Summary
The literature includes 11 studies ranging from 2008 to 2024, encompassing various study types such as RCTs, prospective, and retrospective analyses. These studies explore the device's application in endovascular procedures.
Reported Outcomes
Published studies report that the guidewire introducer set is effective in facilitating vascular access during complex endovascular procedures. It has been shown to improve procedural success rates and reduce the time required for device placement.
Safety Profile
Reported complications include minor vascular trauma and guidewire kinking, which are generally manageable with proper technique. No major adverse events have been consistently reported across studies.
Evidence Limitations
The evidence is limited by small sample sizes and a lack of long-term follow-up data. Further research is needed to establish comprehensive safety profiles and to explore the device's efficacy in diverse patient populations.
Frequently Asked Questions
What are the clinical indications for guidewire introducer set?
The guidewire introducer set is indicated for use in procedures requiring vascular access, such as embolization and endovascular aneurysm repair.
What outcomes have been reported in clinical studies?
Studies report improved procedural success rates and reduced time for device placement when using the guidewire introducer set.
What complications have been reported?
Safety data indicate minor vascular trauma and guidewire kinking as potential complications, with no major adverse events consistently reported.
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.