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acumen single-lumen delivery sheath
Acumen Medical
Summary: The Acumen Single-Lumen Delivery Sheath is a medical device used for the delivery of embolization coils in vascular procedures. It is primarily utilized by interventional radiologists and vascular surgeons.
FDA Clearance Information
Pathway
510K
Number
K053400 ↗
Decision Date
June 19, 2006
Product Code
DYB
Device Class
Class 2
Evidence
0 studies
The Acumen Single-Lumen Delivery Sheath was cleared through the FDA 510(k) pathway on June 19, 2006. It is manufactured by Acumen Medical and classified as a Class 2 device under product code DYB.
What It Is
The Acumen Single-Lumen Delivery Sheath is a catheter-like device designed to facilitate the delivery of embolization coils into the vascular system. It features a single lumen through which coils are passed to reach the target site. This device is crucial in procedures aiming to occlude blood vessels, often to treat aneurysms or prevent blood flow to certain areas.
Clinical Applications
This device is commonly used in interventional radiology and vascular surgery settings. It is employed in procedures such as embolization to treat conditions like aneurysms, arteriovenous malformations, or to control bleeding. The sheath is used in hospitals and specialized clinics, primarily for adult patients requiring vascular interventions.
Indications for Use
The FDA-cleared indications for this device include the delivery of embolization coils to occlude blood vessels. It is intended for patients who require vascular embolization to treat or prevent conditions like aneurysms or other vascular abnormalities.
Practical Considerations
The Acumen Single-Lumen Delivery Sheath is available in various sizes to accommodate different vascular anatomies. It is compatible with standard embolization coils and requires careful handling to ensure precise placement. Clinicians should be trained in vascular access techniques for optimal use.
Frequently Asked Questions
What is the Acumen Single-Lumen Delivery Sheath used for?
It is used for the delivery of embolization coils to occlude blood vessels in various vascular procedures.
What specialties typically use this device?
Interventional radiologists and vascular surgeons commonly use this device.
What are the FDA-cleared indications?
The device is indicated for the delivery of embolization coils to occlude blood vessels, treating conditions like aneurysms.
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.