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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 ?
510(k)
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.
FDA-Cleared Indications
- The FDA record lists the device under product code BSN and 510(k) K133004, cleared in 2014.
- The available FDA indication summary does not state a specific clinical indication beyond the device classification and clearance.
Clinical Applications
- Use only as described in the complete FDA-cleared labeling and instructions for use.
- Use as a vented filter component in a compatible vascular procedure when specified by the manufacturer.
Practical Considerations
- Confirm the exact device model, configuration, intended use, and compatible equipment in the current manufacturer instructions for use before use.
- Do not assume that the device is a stent, stent-delivery system, or treatment for peripheral artery disease based only on the product name or secondary descriptions.
- Verify the available sizes, connections, pressure limits, flow direction, and venting requirements before the procedure.
- MRI safety, MRI conditional labeling, or MRI contraindications are not established in the information provided; consult the current product labeling.
- Use is contraindicated when the device, accessories, or procedure are incompatible with the patient's anatomy or when the manufacturer's warnings and contraindications apply.
Procedures that use this device
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.