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modified acumen lead delivery sheath with stylet model spirit-10 5-59
Acumen Medical
Summary: The modified Acumen lead delivery sheath with stylet model Spirit-10 5-59 is a medical device used for the delivery of embolization coils. It is typically used by interventional radiologists or cardiologists in procedures requiring precise placement of coils.
FDA Clearance Information
Pathway
510K
Number
K083855 ↗
Decision Date
February 17, 2009
Product Code
DYB
Device Class
Class 2
Evidence
0 studies
The device was cleared through the FDA 510(k) pathway on February 17, 2009, by Acumen Medical. It is classified as a Class 2 device under product code DYB.
What It Is
The modified Acumen lead delivery sheath with stylet model Spirit-10 5-59 is designed to facilitate the delivery of embolization coils into the vascular system. It consists of a sheath and a stylet, which together help in guiding the coils to the desired location within the blood vessels. This device is essential for procedures that require precise navigation and placement of coils to achieve therapeutic embolization.
Clinical Applications
This device is commonly used in interventional radiology and cardiology settings for procedures such as treating aneurysms or arteriovenous malformations. It is particularly useful in hospital environments where vascular access and coil deployment are needed. The patient population typically includes those with vascular abnormalities requiring embolization to prevent hemorrhage or reduce blood flow to specific areas.
Indications for Use
The FDA-cleared indications for this device involve its use in delivering embolization coils, which are used to block or reduce blood flow in targeted vessels. This is particularly relevant for patients with vascular conditions that necessitate controlled embolization.
Practical Considerations
The sheath is designed to be compatible with a range of embolization coils and should be selected based on the specific size and type of coil being used. Clinicians should be familiar with the technique of coil deployment and ensure that the sheath is appropriately sized for the vascular access site.
Frequently Asked Questions
What is the modified Acumen lead delivery sheath used for?
It is used for delivering embolization coils into the vascular system to treat conditions like aneurysms or arteriovenous malformations.
What specialties typically use this device?
Interventional radiologists and cardiologists typically use this device during procedures that require embolization.
What are the FDA-cleared indications?
The device is indicated for the delivery of embolization coils to block or reduce blood flow in targeted blood vessels.
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.