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vygon split cannula introducer
Vygon
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
510K
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.
Clinical Applications
This device is commonly used in interventional radiology and vascular surgery settings. It is ideal for procedures involving the placement of central venous catheters, such as in patients requiring long-term intravenous therapy or hemodialysis. The device is suitable for use in both hospital and outpatient settings, catering to a wide range of patient populations, including those with chronic conditions requiring frequent vascular access.
Indications for Use
The FDA-cleared indications for the Vygon Split Cannula Introducer include its use in facilitating catheter placement in the vascular system. It is intended for patients who require central venous access for treatments such as chemotherapy, parenteral nutrition, or dialysis.
Practical Considerations
The Vygon Split Cannula Introducer is available in various sizes to accommodate different patient anatomies and catheter types. It is compatible with a range of catheter materials and designs. Clinicians should be familiar with the insertion technique to ensure optimal outcomes and minimize complications.
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.