📋 FDA Reference
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 ?
510(k)
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.
FDA-Cleared Indications
- Delivery of embolization coils through the vasculature to a selected treatment site.
- Use in procedures intended to occlude or reduce blood flow in a targeted blood vessel or vascular lesion.
Clinical Applications
- Delivery of embolization coils during treatment of selected aneurysms.
- Delivery of embolization coils for vascular malformations, when coil embolization is clinically appropriate.
- Catheter-based vascular embolization procedures performed by trained interventional specialists.
Practical Considerations
- Available models include LDS-10-57, LDS-10-57-90, LDS-10-64, and LDS-10-64-90; the appropriate model depends on the target anatomy and procedural approach.
- Confirm compatibility with the planned embolization coils, guidewires, catheters, and other accessories before use.
- The operator selects the access site, sheath size, and length based on vessel diameter, tortuosity, target location, and required support.
- Use requires fluoroscopic or other appropriate imaging guidance by trained personnel.
- The FDA record provided does not establish MRI safety; follow the current device labeling and institutional MRI policy before scanning.
Procedures that use this device
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.