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safetynet guidewire introducer
Injectimed
Summary: The Safetynet Guidewire Introducer by Injectimed is a medical device used to facilitate the insertion of guidewires during interventional procedures. It is primarily used by interventional radiologists and cardiologists.
FDA Clearance Information
Pathway
510K
Number
K040029 ↗
Decision Date
April 5, 2004
Product Code
DYB
Device Class
Class 2
Evidence
0 studies
The Safetynet Guidewire Introducer was cleared through the FDA 510(k) pathway on April 5, 2004. Manufactured by Injectimed, it is classified as a Class 2 device under product code DYB.
What It Is
The Safetynet Guidewire Introducer is a device designed to assist in the safe and effective placement of guidewires into the vascular system. It typically consists of a sheath and dilator that allows for smooth passage of guidewires, minimizing trauma to the vessel walls. This device is crucial in ensuring accurate guidewire placement, which is essential for subsequent catheter-based interventions.
Clinical Applications
This device is commonly used in interventional radiology and cardiology procedures, such as angiography, embolization, and stent placement. It is particularly useful in settings where precise guidewire placement is critical, such as in the treatment of vascular occlusions or aneurysms. The Safetynet Guidewire Introducer is used in both hospital and outpatient settings, catering to adult and pediatric patient populations requiring vascular access.
Indications for Use
The FDA-cleared indications for the Safetynet Guidewire Introducer include its use in facilitating the insertion of guidewires during various interventional procedures. It is intended for patients requiring vascular access for diagnostic or therapeutic purposes.
Practical Considerations
The Safetynet Guidewire Introducer is available in various sizes to accommodate different vessel diameters and guidewire specifications. It is compatible with standard guidewires and should be used with care to avoid vessel trauma. Clinicians should be familiar with the device's handling and insertion techniques to ensure optimal outcomes.
Frequently Asked Questions
What is the Safetynet Guidewire Introducer used for?
It is used to facilitate the insertion of guidewires during interventional procedures, ensuring safe and accurate vascular access.
What specialties typically use this device?
Interventional radiologists and cardiologists commonly use this device in procedures requiring vascular access.
What are the FDA-cleared indications?
The device is indicated for facilitating guidewire insertion in patients needing vascular access for diagnostic or therapeutic interventions.
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.