đź“‹ FDA Reference
modification to acumen single-lumen delivery sheath models bls-8-45 bls-7-45 bls-6-45
Acumen Medical
Summary: The Acumen Single-Lumen Delivery Sheath is a medical device used for the delivery of embolization coils. It is primarily utilized by interventional radiologists and vascular surgeons.
FDA Clearance Information
Pathway
510K
Number
K070396 ↗
Decision Date
May 22, 2007
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 May 22, 2007. It is manufactured by Acumen Medical and classified as a Class 2 device.
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 that allows for precise placement of coils to occlude blood vessels, typically to treat aneurysms or arteriovenous malformations. The device is engineered to provide flexibility and control during endovascular procedures.
Clinical Applications
This delivery sheath is commonly used in interventional radiology and vascular surgery settings. It is employed in procedures requiring the embolization of blood vessels, such as in the treatment of cerebral aneurysms or gastrointestinal bleeding. The device is suitable for adult patients and can be used in both hospital and outpatient settings.
Indications for Use
The FDA-cleared indications for this device involve its use in delivering embolization coils to occlude blood vessels. This is typically indicated for patients with conditions like aneurysms or vascular malformations that require endovascular intervention.
Practical Considerations
The device is available in various sizes, typically ranging from 6 to 8 French, to accommodate different vessel sizes. It is compatible with standard embolization coils and requires careful handling to ensure accurate placement. Clinicians should be familiar with catheter-based techniques for optimal 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.
What specialties typically use this device?
Interventional radiologists and vascular surgeons typically use this device.
What are the FDA-cleared indications?
The device is indicated for delivering embolization coils to occlude blood vessels, often in cases of aneurysms or 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.