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hqs introducer
Alseal
Summary: The HQS Introducer by Alseal is a medical device used primarily in interventional radiology for the placement of embolization coils. It is typically used by clinicians specializing in vascular procedures.
FDA Clearance Information
Pathway
510K
Number
K113849 ↗
Decision Date
July 31, 2012
Product Code
DYB
Device Class
Class 2
Evidence
0 studies
The HQS Introducer was cleared via the FDA 510(k) pathway on July 31, 2012. Manufactured by Alseal, it is classified as a Class 2 device under product code DYB.
What It Is
The HQS Introducer is a medical device designed to facilitate the introduction of embolization coils into the vascular system. It consists of a sheath and dilator that provide a conduit for the safe and efficient delivery of coils to targeted vessels. This device is crucial in procedures aiming to occlude blood vessels, often to control bleeding or reduce blood flow to a particular area.
Clinical Applications
The HQS Introducer is commonly used in interventional radiology and vascular surgery. It is particularly useful in procedures requiring the embolization of blood vessels, such as treating aneurysms, arteriovenous malformations, or controlling hemorrhage. The device is typically used in hospital settings, catering to patients with vascular abnormalities or trauma.
Indications for Use
The FDA-cleared indications for the HQS Introducer involve its use in facilitating the placement of embolization coils. It is suitable for patients requiring vascular embolization to manage conditions like aneurysms or to control bleeding.
Practical Considerations
The HQS Introducer is available in various sizes to accommodate different vessel diameters and coil sizes. It is compatible with standard embolization coils and requires careful technique to ensure proper placement and minimize complications.
Frequently Asked Questions
What is HQS Introducer used for?
The HQS Introducer is used for the placement of embolization coils in vascular procedures.
What specialties typically use this device?
Interventional radiologists and vascular surgeons typically use the HQS Introducer.
What are the FDA-cleared indications?
The device is indicated for use in facilitating the placement of embolization coils to manage vascular conditions.
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.