đź“‹ FDA Reference
ancure sheath model 40315 40320 40325
Guidant Cardiac And Vascular Surgery
Summary: The Ancure Sheath is a medical device used in vascular procedures, primarily for embolization. It is utilized by interventional radiologists and vascular surgeons to facilitate the delivery of embolization coils.
FDA Clearance Information
Pathway
510K
Number
K003889 ↗
Decision Date
January 24, 2002
Product Code
DYB
Device Class
Class 2
Evidence
0 studies
The Ancure Sheath, manufactured by Guidant Cardiac And Vascular Surgery, was cleared through the FDA 510(k) pathway on January 24, 2002. It is classified as a Class 2 device under product code DYB.
What It Is
The Ancure Sheath is a specialized medical device designed to assist in the delivery of embolization coils during vascular procedures. It acts as a conduit, allowing for the precise placement of coils within blood vessels to obstruct blood flow to specific areas. This device is essential for procedures aiming to treat aneurysms or prevent hemorrhage by occluding blood vessels.
Clinical Applications
Commonly used in interventional radiology and vascular surgery, the Ancure Sheath is employed in procedures requiring embolization. It is particularly useful in treating conditions such as arteriovenous malformations, aneurysms, and certain types of tumors. The device is suitable for use in hospital settings, catering to adult and geriatric patient populations who require vascular intervention.
Indications for Use
The FDA indications for the Ancure Sheath involve its use in embolization procedures. It is intended for patients who need blood flow obstruction in specific vessels, often due to aneurysms or vascular malformations.
Practical Considerations
The Ancure Sheath comes in various sizes (models 40315, 40320, 40325) to accommodate different vessel diameters. It is compatible with standard embolization coils and requires careful handling to ensure precise placement. Clinicians should be familiar with vascular anatomy and have experience in endovascular techniques for optimal use.
Frequently Asked Questions
What is the Ancure Sheath used for?
The Ancure Sheath is used for delivering embolization coils during vascular procedures to obstruct blood flow in targeted vessels.
What specialties typically use this device?
Interventional radiologists and vascular surgeons typically use the Ancure Sheath in their procedures.
What are the FDA-cleared indications?
The Ancure Sheath is indicated for use in embolization procedures to occlude blood flow in specific vessels, often for treating 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.