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the cvc wand safety introducer with valved peelable sheath
Access Scientific
Summary: The CVC Wand Safety Introducer with Valved Peelable Sheath is a medical device used for the safe introduction of central venous catheters. It is typically utilized by interventional radiologists and vascular surgeons.
FDA Clearance Information
Pathway
510K
Number
K131148 ↗
Decision Date
September 4, 2013
Product Code
DYB
Device Class
Class 2
Evidence
0 studies
The CVC Wand Safety Introducer was cleared through the FDA 510(k) pathway on September 4, 2013, by Access Scientific. It is classified as a Class 2 medical device under product code DYB.
What It Is
The CVC Wand Safety Introducer is a device designed to facilitate the insertion of central venous catheters. It features a valved peelable sheath that helps maintain a sterile field and reduces the risk of air embolism during catheter placement. This device is particularly useful in procedures requiring precise and safe vascular access.
Clinical Applications
This device is commonly used in hospital settings, particularly in the intensive care unit (ICU) and operating rooms, for patients requiring central venous access. It is frequently employed in procedures such as central line placement for hemodynamic monitoring, medication administration, or dialysis. Specialties that commonly use this device include critical care, anesthesiology, and interventional radiology.
Indications for Use
The CVC Wand Safety Introducer is indicated for use in patients who require central venous catheterization. It is suitable for a variety of conditions where central access is necessary, such as in critically ill patients or those needing long-term intravenous therapy.
Practical Considerations
The device is available in various sizes to accommodate different patient anatomies and catheter types. It is compatible with standard central venous catheters and requires familiarity with central line insertion techniques. Proper aseptic technique is crucial to prevent infection.
Frequently Asked Questions
What is the CVC Wand Safety Introducer used for?
It is used for the safe and efficient introduction of central venous catheters in patients requiring central venous access.
What specialties typically use this device?
Specialties such as critical care, anesthesiology, and interventional radiology commonly use this device.
What are the FDA-cleared indications?
The device is indicated for central venous catheterization in patients needing central access for various medical conditions.
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.