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spectra guidewire introducer needle
Spectra Medical Devices
Summary: The Spectra Guidewire Introducer Needle is a medical device used to facilitate the insertion of guidewires during vascular procedures. It is typically used by interventional radiologists and cardiologists.
FDA Clearance Information
Pathway
510K
Number
K082580 ↗
Decision Date
December 8, 2008
Product Code
DYB
Device Class
Class 2
Evidence
0 studies
The Spectra Guidewire Introducer Needle was cleared by the FDA via the 510(k) pathway on December 8, 2008. It is manufactured by Spectra Medical Devices and is classified as a Class 2 device under product code DYB.
What It Is
The Spectra Guidewire Introducer Needle is a specialized needle designed to aid in the insertion of guidewires into blood vessels. It features a hollow bore through which guidewires can be introduced, ensuring precision and reducing the risk of vascular trauma. This device is essential in procedures requiring vascular access, such as angiography or the placement of embolization coils.
Clinical Applications
This device is commonly used in interventional radiology and cardiology settings. It is essential for procedures that require vascular access, such as angioplasty, stent placement, and embolization. The device is used in hospitals and outpatient surgical centers, primarily by specialists dealing with cardiovascular and peripheral vascular conditions.
Indications for Use
The FDA indications for this device involve its use in facilitating the insertion of guidewires during procedures that require vascular access. It is suitable for patients undergoing interventions like embolization or angiography.
Practical Considerations
The Spectra Guidewire Introducer Needle is available in various sizes to accommodate different patient anatomies and procedural requirements. It is compatible with standard guidewires and should be used with care to minimize the risk of vascular injury. Proper technique is essential for successful outcomes.
Frequently Asked Questions
What is the Spectra Guidewire Introducer Needle used for?
It is used to facilitate the insertion of guidewires during vascular procedures, such as angiography and embolization.
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 use in facilitating the insertion of guidewires during procedures requiring vascular access.
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.