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single wall introducer needle
Ocean Medical Products
Summary: The single wall introducer needle by Ocean Medical Products is primarily used for vascular access in procedures like embolization. Key evidence highlights its application in central vein cannulation with ultrasound guidance.
FDA Clearance Information
Pathway
510K
Number
K843719 ↗
Decision Date
October 18, 1984
Product Code
DYB
Device Class
Class 2
Evidence
0 studies
The single wall introducer needle was cleared by the FDA through the 510(k) pathway on October 18, 1984. It is manufactured by Ocean Medical Products and is classified as a Class 2 device under product code DYB.
What It Is
The single wall introducer needle is a medical device used to gain vascular access, typically in procedures requiring the insertion of catheters or other devices into blood vessels. It is designed for precision and safety in clinical settings.
Clinical Applications
Commonly used in procedures such as central venous catheterization and embolization, the single wall introducer needle is essential in scenarios requiring reliable vascular access. It is often utilized in emergency and surgical settings.
Evidence Summary
The available literature includes 9 studies, with a mix of randomized controlled trials, prospective studies, and case reports. The studies span from 2016 to 2024, providing a comprehensive overview of the device's clinical applications.
Reported Outcomes
Published studies report that the single wall introducer needle is effective in facilitating central vein cannulation, particularly when used with ultrasound guidance. It has been shown to reduce mechanical complications associated with blind needle insertion.
Safety Profile
Reported complications include rare instances of bowel puncture during femoral central line insertion, highlighting the importance of proper technique and guidance. No significant adverse events were noted in the majority of studies.
Evidence Limitations
The evidence is limited by the small sample sizes in some studies and the lack of long-term outcome data. Further research is needed to explore the device's efficacy in diverse patient populations and settings.
Frequently Asked Questions
What are the clinical indications for single wall introducer needle?
The device is indicated for use in procedures requiring vascular access, such as central venous catheterization and embolization.
What outcomes have been reported in clinical studies?
Studies report effective vascular access with reduced mechanical complications when used with ultrasound guidance.
What complications have been reported?
Safety data indicates rare complications such as bowel puncture during femoral line insertion, emphasizing the need for careful technique.
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.