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guidewire introducer safety needle
Medamicus
Summary: The guidewire introducer safety needle by Medamicus is used primarily for vascular access procedures. Key evidence highlights its role in enhancing precision during procedures like percutaneous dilatational tracheostomy.
FDA Clearance Information
Pathway
510K
Number
K011085 ↗
Decision Date
July 9, 2001
Product Code
DYB
Device Class
Class 2
Evidence
0 studies
The guidewire introducer safety needle was cleared by the FDA through the 510(k) pathway on July 9, 2001. It is manufactured by Medamicus and classified as a Class 2 medical device.
What It Is
The guidewire introducer safety needle is a medical device designed to facilitate the introduction of guidewires into the vascular system. It is commonly used in procedures requiring precise vascular access.
Clinical Applications
This device is frequently used in clinical scenarios such as percutaneous dilatational tracheostomy and other procedures requiring accurate guidewire placement. It is particularly useful in settings where ultrasound guidance is employed.
Evidence Summary
The available literature includes 11 studies, comprising various study types such as RCTs and observational studies, conducted between 2015 and 2024. These studies explore the device's application in different clinical settings.
Reported Outcomes
Published studies report that the guidewire introducer safety needle enhances precision in procedures like percutaneous dilatational tracheostomy. It has been shown to facilitate accurate guidewire placement, potentially improving procedural success rates.
Safety Profile
Reported complications include potential issues with guidewire placement accuracy when not used with adjunct imaging techniques. However, the device is generally considered safe when used as intended.
Evidence Limitations
Current evidence is limited by the small sample sizes and the lack of long-term outcome data. Further research is needed to explore the device's efficacy across diverse patient populations and clinical settings.
Frequently Asked Questions
What are the clinical indications for guidewire introducer safety needle?
The guidewire introducer safety needle is indicated for use in procedures requiring precise vascular access, such as percutaneous dilatational tracheostomy.
What outcomes have been reported in clinical studies?
Studies have reported improved precision in guidewire placement and potential enhancements in procedural success rates.
What complications have been reported?
Safety data indicate potential issues with guidewire placement accuracy, particularly when not used with imaging guidance.
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.