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vented millex -gv cathivex -gv
Merck Millipore
Summary: The Vented Millex -GV Cathivex -GV is a medical device used primarily in peripheral stenting procedures. It is utilized by interventional radiologists and vascular surgeons to ensure proper stent placement and function.
FDA Clearance Information
Pathway 510K
Number K133004 ↗
Decision Date March 27, 2014
Product Code BSN
Device Class Class 2
Evidence 0 studies
The Vented Millex -GV Cathivex -GV was cleared by the FDA through the 510(k) pathway on March 27, 2014. Manufactured by Merck Millipore, it is classified as a Class 2 device under product code BSN.
What It Is
The Vented Millex -GV Cathivex -GV is a specialized filter device designed to assist in peripheral vascular procedures. It functions by providing a vented pathway that helps in the deployment and management of stents within peripheral arteries. This device is crucial in maintaining patency and preventing complications during stenting.
Clinical Applications
This device is commonly used in interventional radiology and vascular surgery settings. It is particularly useful in procedures involving the placement of stents in peripheral arteries, such as those in the legs or arms. The device is suitable for adult patients who require intervention due to peripheral artery disease or other vascular conditions.
Indications for Use
The FDA indications suggest that this device is intended for use in patients undergoing peripheral stenting procedures. It is designed to aid in the safe and effective placement of stents, ensuring that blood flow is restored in affected arteries.
Practical Considerations
The Vented Millex -GV Cathivex -GV is compatible with standard stenting equipment and is available in various sizes to accommodate different vessel diameters. Clinicians should be familiar with the device's venting mechanism to optimize its use during procedures.
Frequently Asked Questions
What is Vented Millex -GV Cathivex -GV used for?
It is used in peripheral stenting procedures to assist in the deployment and management of stents in peripheral arteries.
What specialties typically use this device?
Interventional radiologists and vascular surgeons typically use this device.
What are the FDA-cleared indications?
The device is indicated for use in peripheral stenting procedures to ensure proper stent placement and function.
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.