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modification to acumen single-lumen delivery sheath models bls-10 bls-9 bls-7
Acumen Medical
Summary: The Acumen Single-Lumen Delivery Sheath is a medical device used in embolization procedures, primarily by interventional radiologists and vascular surgeons. It facilitates the delivery of embolization coils to target sites within the vasculature.
FDA Clearance Information
Pathway
510K
Number
K080500 ↗
Decision Date
March 13, 2008
Product Code
DYB
Device Class
Class 2
Evidence
0 studies
The Acumen Single-Lumen Delivery Sheath, manufactured by Acumen Medical, was cleared via the FDA 510(k) pathway on March 13, 2008. It is classified as a Class 2 device under product code DYB.
What It Is
The Acumen Single-Lumen Delivery Sheath is a specialized catheter designed to assist in the delivery of embolization coils to specific vascular sites. It features a single lumen that allows for precise placement of coils, aiding in the occlusion of blood vessels. This device is particularly useful in minimally invasive procedures where accurate delivery of therapeutic agents is critical.
Clinical Applications
This device is commonly used in interventional radiology and vascular surgery for procedures involving the occlusion of blood vessels, such as treating aneurysms or arteriovenous malformations. It is typically employed in hospital settings, particularly in catheterization labs or interventional suites, and is used in adult and pediatric populations requiring vascular embolization.
Indications for Use
The FDA-cleared indications for this device involve its use in delivering embolization coils to occlude blood vessels. This is particularly beneficial for patients with conditions like aneurysms or vascular malformations that require targeted vessel occlusion.
Practical Considerations
The Acumen Single-Lumen Delivery Sheath comes in various sizes to accommodate different vascular anatomies. It is compatible with standard embolization coils and requires careful handling to ensure precise delivery. Clinicians should be familiar with catheterization techniques to optimize its use.
Frequently Asked Questions
What is the Acumen Single-Lumen Delivery Sheath used for?
It is used for delivering embolization coils to occlude blood vessels in procedures like treating aneurysms or vascular malformations.
What specialties typically use this device?
Interventional radiologists and vascular surgeons typically use this device in hospital settings.
What are the FDA-cleared indications?
The device is indicated for the delivery of embolization coils to occlude blood vessels, useful in treating aneurysms and vascular malformations.
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.