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seldinger safety needle introducer
Hdc
Summary: The Seldinger Safety Needle Introducer by Hdc is a Class 2 medical device used primarily for vascular access. Key evidence highlights its application in various clinical settings, with studies focusing on safety and procedural success.
FDA Clearance Information
Pathway
510K
Number
K032404 ↗
Decision Date
September 10, 2003
Product Code
DYB
Device Class
Class 2
Evidence
0 studies
The Seldinger Safety Needle Introducer was cleared by the FDA via the 510(k) pathway on September 10, 2003. It is manufactured by Hdc and classified as a Class 2 device.
What It Is
The Seldinger Safety Needle Introducer is a medical device designed for safe and effective vascular access. It utilizes the Seldinger technique, which involves the insertion of a needle followed by a guidewire to facilitate catheter placement.
Clinical Applications
This device is commonly used in procedures requiring vascular access, such as central venous catheterization and embolization. It is particularly useful in settings where precision and safety are paramount, such as in interventional radiology and critical care.
Evidence Summary
The available literature includes four studies, ranging from 1982 to 2024, encompassing various study types including RCTs and prospective studies. These studies explore the device's application in both experimental and clinical settings.
Reported Outcomes
Published studies report successful use of the Seldinger Safety Needle Introducer in achieving vascular access with high procedural success rates. The device has been validated in both human and animal models, demonstrating its efficacy in facilitating catheter placement.
Safety Profile
Reported complications include potential risks associated with vascular access procedures, such as bleeding and infection. However, the studies emphasize the device's role in enhancing safety through its design, which minimizes these risks.
Evidence Limitations
The evidence is limited by the small number of studies and the variability in study design. Further research is needed to establish long-term outcomes and to explore its use in diverse patient populations.
Frequently Asked Questions
What are the clinical indications for Seldinger Safety Needle Introducer?
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 high procedural success rates and effective vascular access using the Seldinger Safety Needle Introducer.
What complications have been reported?
Reported complications include bleeding and infection, although the device is designed to minimize these risks.
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.