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modified acumen lead delivery sheath models lds-10-57 lds-10-57-90 lds-10-64 and lds-10-64-90
Acumen Medical
Summary: The modified acumen lead delivery sheath is a medical device used for the delivery of embolization coils. It is primarily used by interventional radiologists and cardiologists.
FDA Clearance Information
Pathway
510K
Number
K062145 ↗
Decision Date
August 23, 2006
Product Code
DYB
Device Class
Class 2
Evidence
0 studies
The device was cleared through the FDA 510(k) pathway on August 23, 2006. Manufactured by Acumen Medical, it is classified as a Class 2 device under product code DYB.
What It Is
The modified acumen lead delivery sheath is a specialized catheter system designed to facilitate the delivery of embolization coils into the vasculature. It is used to navigate through blood vessels to reach target sites where embolization is required. The device is constructed to provide flexibility and support during the procedure, ensuring precise placement of coils.
Clinical Applications
This device is commonly used in interventional radiology and cardiology settings for procedures requiring vascular embolization, such as treating aneurysms or arteriovenous malformations. It is suitable for use in both hospital and outpatient settings, and is typically used in adult patients requiring embolization therapy.
Indications for Use
The FDA-cleared indications for this device involve its use in delivering embolization coils to block blood flow to certain areas, such as in the treatment of aneurysms or vascular malformations. It is intended for patients who require such interventions to manage or prevent vascular conditions.
Practical Considerations
The sheath comes in multiple sizes, such as models lds-10-57 and lds-10-64, to accommodate different anatomical requirements. It is important to select the appropriate size for the patient's vasculature to ensure effective coil delivery. Compatibility with various coil systems should be confirmed prior to the procedure.
Frequently Asked Questions
What is the modified acumen lead delivery sheath used for?
It is used for the delivery of embolization coils into the vasculature to treat conditions like aneurysms and arteriovenous malformations.
What specialties typically use this device?
Interventional radiologists and cardiologists typically use this device in procedures involving vascular embolization.
What are the FDA-cleared indications?
The device is indicated for the delivery of embolization coils to block blood flow in conditions such as aneurysms and 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.