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acumen lead delivery sheath with stylet models lds-10-64-sty and lds-10-57-sty
Acumen Medical
Summary: The Acumen Lead Delivery Sheath with Stylet is a medical device used for the delivery of leads in embolization procedures. It is primarily used by interventional radiologists and cardiologists.
FDA Clearance Information
Pathway
510K
Number
K070197 ↗
Decision Date
February 23, 2007
Product Code
DYB
Device Class
Class 2
Evidence
0 studies
The Acumen Lead Delivery Sheath with Stylet was cleared through the FDA 510(k) pathway on February 23, 2007. It is manufactured by Acumen Medical and classified as a Class 2 device under product code DYB.
What It Is
The Acumen Lead Delivery Sheath with Stylet is a specialized medical device designed to facilitate the precise placement of leads during embolization procedures. It consists of a sheath and a stylet, which together provide stability and control during the insertion process. This device is crucial for ensuring accurate lead placement, minimizing the risk of complications.
Clinical Applications
This device is commonly used in interventional radiology and cardiology settings for procedures involving the placement of embolization coils. It is particularly useful in treating conditions such as arteriovenous malformations or aneurysms where precise lead delivery is critical. The device is typically used in hospital settings, catering to adult and pediatric patient populations requiring embolization therapy.
Indications for Use
The Acumen Lead Delivery Sheath is indicated for use in procedures requiring the delivery of leads, such as embolization. It is suitable for patients who need precise placement of embolization coils to treat vascular abnormalities.
Practical Considerations
The device is available in different sizes, such as models LDS-10-64-STY and LDS-10-57-STY, to accommodate various anatomical requirements. It is compatible with standard embolization coils and requires careful handling to ensure optimal lead placement. Clinicians should be familiar with the device's operation and the specific techniques for its use.
Frequently Asked Questions
What is the Acumen Lead Delivery Sheath used for?
It is used for delivering leads during embolization procedures to treat vascular abnormalities.
What specialties typically use this device?
Interventional radiologists and cardiologists typically use this device.
What are the FDA-cleared indications?
The device is indicated for the delivery of leads in embolization procedures, particularly for treating vascular conditions like arteriovenous 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.