📋 FDA Reference
Vygon Split Cannula Introducer
Summary: The Vygon Split Cannula Introducer is a medical device used primarily for the insertion of catheters in vascular procedures. It is commonly used by interventional radiologists and vascular surgeons.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K010913 ↗
Decision Date ?
September 28, 2001
Product Code ?
DYB
Device Class ?
Class 2
Evidence ?
0 studies
The Vygon Split Cannula Introducer was cleared through the FDA 510k pathway on September 28, 2001. It is manufactured by Vygon and classified as a Class 2 device under product code DYB.
What It Is
The Vygon Split Cannula Introducer is a specialized medical device designed to facilitate the insertion of catheters into the vascular system. It consists of a split cannula that allows for smooth and controlled catheter placement, minimizing trauma to the vessel. This device is particularly useful in procedures requiring precise catheter positioning, such as central venous access.
FDA-Cleared Indications
- Facilitation of catheter placement in the vascular system.
Clinical Applications
- Introducing vascular catheters during interventional procedures.
- Facilitating placement of central venous catheters when vascular access is required.
- Supporting catheter placement for treatments that require central venous access, such as long-term intravenous therapy, chemotherapy, parenteral nutrition, or dialysis, when consistent with the specific product labeling and clinical technique.
Practical Considerations
- The appropriate size should be selected for the target vessel, catheter, and patient anatomy.
- Confirm compatibility between the introducer, catheter, guidewire, and other components before use.
- Use sterile technique and imaging guidance as appropriate for the access site and procedure.
- The record provided does not establish MRI safety. Check the current Vygon labeling for MR Safe, MR Conditional, or MR Unsafe status before MRI.
- Potential complications are related to vascular access and catheter introduction, including bleeding, infection, vessel injury, thrombosis, air embolism, and malposition. Patient-specific contraindications and precautions should be reviewed before use.
Frequently Asked Questions
What is the Vygon Split Cannula Introducer used for?
It is used for the insertion of catheters into the vascular system, particularly in procedures requiring central venous access.
What specialties typically use this device?
Interventional radiologists and vascular surgeons commonly use this device.
What are the FDA-cleared indications?
The device is indicated for facilitating catheter placement in the vascular system, suitable for patients needing central venous access.
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.