đź“‹ FDA Reference
vessix guide sheath 7f 45 cm rdc vessix guide sheath 7f 45cm lima
Boston Scientific
Summary: The Vessix Guide Sheath 7F 45cm is a medical device used in vascular procedures, primarily by interventional radiologists and cardiologists. It facilitates the delivery of embolization coils and other devices.
FDA Clearance Information
Pathway
510K
Number
K140641 ↗
Decision Date
July 3, 2014
Product Code
DYB
Device Class
Class 2
Evidence
0 studies
The Vessix Guide Sheath 7F 45cm, manufactured by Boston Scientific, was cleared through the FDA 510(k) pathway on July 3, 2014. It is a Class 2 device under the product code DYB.
What It Is
The Vessix Guide Sheath 7F 45cm is a flexible, tubular device designed to provide a conduit for the introduction of interventional tools into the vascular system. It is typically used to facilitate the placement of embolization coils and other therapeutic devices during minimally invasive procedures. The sheath's design allows for easy navigation through the vascular system, providing stability and support to the devices being delivered.
Clinical Applications
This guide sheath is commonly used in interventional radiology and cardiology for procedures involving the embolization of blood vessels, such as in the treatment of aneurysms or arteriovenous malformations. It is particularly useful in settings where precise delivery of embolization coils is required. The device is suitable for use in a variety of patient populations, including those with complex vascular anatomies.
Indications for Use
The FDA indications for the Vessix Guide Sheath include its use in procedures requiring the delivery of embolization coils. It is intended for patients who need vascular interventions to treat conditions like aneurysms or other vascular abnormalities.
Practical Considerations
The Vessix Guide Sheath is available in a 7F size, which is compatible with a range of embolization devices. Clinicians should ensure compatibility with the specific devices they plan to use. Proper technique in navigating the sheath through the vascular system is essential to avoid complications.
Frequently Asked Questions
What is the Vessix Guide Sheath 7F 45cm used for?
It is used to facilitate the delivery of embolization coils and other interventional devices into the vascular system during minimally invasive procedures.
What specialties typically use this device?
Interventional radiologists and cardiologists typically use this device in vascular procedures.
What are the FDA-cleared indications?
The device is indicated for use in procedures requiring the delivery of embolization coils, such as in the treatment of aneurysms or vascular abnormalities.
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.