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hqs introducer model 2064-hqs
Alseal
Summary: The HQS Introducer Model 2064-HQS by Alseal is a medical device used for the insertion of embolization coils. It is primarily used by interventional radiologists and vascular surgeons in procedures to treat vascular abnormalities.
FDA Clearance Information
Pathway
510K
Number
K153494 ↗
Decision Date
August 25, 2016
Product Code
DYB
Device Class
Class 2
Evidence
0 studies
The HQS Introducer Model 2064-HQS was cleared through the FDA 510(k) pathway on August 25, 2016. Manufactured by Alseal, it is classified as a Class 2 device under product code DYB.
What It Is
The HQS Introducer Model 2064-HQS is a specialized medical device designed to facilitate the insertion of embolization coils into blood vessels. It works by providing a stable and precise pathway for the coils, ensuring accurate placement within the vascular system. This device is essential in procedures aimed at controlling bleeding or reducing blood flow to certain areas, such as tumors or aneurysms.
Clinical Applications
Commonly used in interventional radiology and vascular surgery, the HQS Introducer is employed in procedures like embolization to treat conditions such as arteriovenous malformations, aneurysms, and certain types of tumors. It is typically used in hospital settings, particularly in catheterization labs, and is suitable for adult and pediatric patients requiring vascular interventions.
Indications for Use
The FDA-cleared indications for this device involve its use in the delivery of embolization coils to treat vascular abnormalities. This includes patients with conditions that require the occlusion of blood vessels to prevent hemorrhage or reduce blood supply to specific areas.
Practical Considerations
When using the HQS Introducer, clinicians should consider the size and compatibility with various embolization coils. Proper technique is crucial for ensuring successful coil deployment and minimizing complications. Familiarity with vascular anatomy and imaging guidance is essential for optimal use.
Frequently Asked Questions
What is the HQS Introducer Model 2064-HQS used for?
It is used for the insertion of embolization coils to treat vascular abnormalities.
What specialties typically use this device?
Interventional radiologists and vascular surgeons typically use this device.
What are the FDA-cleared indications?
It is indicated for the delivery of embolization coils to treat conditions requiring vascular occlusion.
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.