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modified acumen sheath model ttw 10-65
Acumen Medical
Summary: The Modified Acumen Sheath Model TTW 10-65 is a medical device used primarily for embolization procedures. It is utilized by interventional radiologists and vascular surgeons to deliver embolization coils in various clinical settings.
FDA Clearance Information
Pathway
510K
Number
K051515 ↗
Decision Date
September 1, 2005
Product Code
DYB
Device Class
Class 2
Evidence
0 studies
The Modified Acumen Sheath Model TTW 10-65 was cleared through the FDA 510(k) pathway on September 1, 2005. Manufactured by Acumen Medical, it is classified as a Class 2 device under product code DYB.
What It Is
The Modified Acumen Sheath Model TTW 10-65 is a specialized catheter sheath designed to facilitate the delivery of embolization coils. It provides a conduit for the precise placement of coils within blood vessels to occlude blood flow to targeted areas, such as aneurysms or vascular malformations. This device is integral in minimally invasive procedures, offering enhanced control and accuracy during embolization.
Clinical Applications
This device is commonly used in interventional radiology and vascular surgery for embolization procedures. It is particularly useful in treating patients with aneurysms, arteriovenous malformations, or other conditions requiring targeted vessel occlusion. The sheath is typically employed in hospital settings, including catheterization labs and operating rooms, where precision and control are paramount.
Indications for Use
The FDA-cleared indications for this device include use in embolization procedures where coils are needed to occlude blood vessels. It is suitable for patients with conditions such as aneurysms or vascular malformations that require targeted embolization to prevent or control bleeding.
Practical Considerations
The Modified Acumen Sheath Model TTW 10-65 is available in various sizes to accommodate different vessel diameters and procedural requirements. It is compatible with standard embolization coils and requires careful handling to ensure proper placement. Clinicians should be familiar with catheterization techniques to optimize the use of this device.
Frequently Asked Questions
What is the Modified Acumen Sheath Model TTW 10-65 used for?
It is used for delivering embolization coils to occlude blood vessels in procedures such as treating aneurysms or vascular malformations.
What specialties typically use this device?
Interventional radiologists and vascular surgeons typically use this device in embolization procedures.
What are the FDA-cleared indications?
The device is indicated for use in embolization procedures requiring coil delivery to occlude 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.