📋 FDA Reference
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 ?
510(k)
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.
FDA-Cleared Indications
- Delivery of embolization coils into blood vessels.
- Use in procedures intended to occlude or block selected blood vessels.
Clinical Applications
- Delivering embolization coils during vascular embolization.
- Coil embolization of selected arteries or veins when vessel occlusion is clinically indicated.
- Supporting catheter-based embolization procedures performed by trained vascular specialists.
Practical Considerations
- The sheath is available in different sizes; the appropriate size depends on the access vessel, target anatomy and embolization system being used.
- It is intended for use with compatible embolization coils and related delivery equipment. Clinicians should confirm size and compatibility before the procedure.
- Placement is performed under imaging guidance, usually fluoroscopy, through vascular access such as the femoral or radial artery, depending on the procedure.
- The device is intended for single-procedure use and should be handled by clinicians trained in vascular access and embolization techniques.
- MRI safety information should be confirmed in the device labeling before MRI. Do not assume the sheath is MR Safe or MR Conditional without manufacturer-specific documentation.
Procedures that use this device
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.