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introducer needle several sizes
Mediziv Medical Products 1987
Summary: The introducer needle by Mediziv Medical Products is used for vascular access in embolization procedures. Key evidence includes studies on its use in various clinical settings.
FDA Clearance Information
Pathway
510K
Number
K933522 ↗
Decision Date
February 21, 1995
Product Code
DYB
Device Class
Class 2
Evidence
0 studies
The introducer needle received FDA clearance through the 510(k) pathway on February 21, 1995. It is manufactured by Mediziv Medical Products 1987 and classified as a Class 2 device.
What It Is
The introducer needle is a medical device used to gain vascular access, particularly in embolization procedures. It is designed to facilitate the insertion of catheters or other devices into the vascular system.
Clinical Applications
Commonly used in procedures requiring vascular access, such as embolization-coils, the introducer needle is essential in interventional radiology and cardiology for precise catheter placement.
Evidence Summary
The literature includes 9 studies, ranging from randomized controlled trials to retrospective analyses, published between 2009 and 2024. These studies explore various applications and outcomes of the introducer needle.
Reported Outcomes
Published studies report that the introducer needle is effective in facilitating vascular access for embolization procedures. It has been used successfully in both animal models and human clinical settings, demonstrating its versatility and reliability.
Safety Profile
Reported complications include potential vascular injury and bleeding, which are inherent risks in procedures involving vascular access. However, the studies reviewed did not report any significant adverse events directly attributable to the device.
Evidence Limitations
The evidence is limited by the small number of studies directly evaluating the introducer needle. Further research is needed to explore long-term outcomes and compare its efficacy with other similar devices.
Frequently Asked Questions
What are the clinical indications for introducer needle several sizes?
The introducer needle is indicated for use in procedures requiring vascular access, such as embolization-coils and other interventional radiology applications.
What outcomes have been reported in clinical studies?
Clinical studies have reported successful vascular access and device placement with the introducer needle, highlighting its effectiveness in various procedural contexts.
What complications have been reported?
Safety data from evidence indicate potential complications such as vascular injury and bleeding, though no significant adverse events were 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.