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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 to facilitate the safe insertion of central venous catheters. It is primarily used by interventional radiologists and vascular surgeons.
FDA Clearance Information
Pathway
510K
Number
K182243 ↗
Decision Date
September 18, 2018
Product Code
DYB
Device Class
Class 2
Evidence
0 studies
The CVC Wand Safety Introducer was cleared through the FDA 510k pathway on September 18, 2018. Manufactured by Access Scientific, it is classified as a Class 2 device under product code DYB.
What It Is
The CVC Wand Safety Introducer with Valved Peelable Sheath is designed to aid in the insertion of central venous catheters. It features a valved peelable sheath that minimizes blood loss and air embolism during catheter placement. The device allows for a smooth transition from needle to catheter, enhancing procedural safety and efficiency.
Clinical Applications
This device is commonly used in procedures requiring central venous access, such as chemotherapy administration, hemodialysis, and parenteral nutrition. It is frequently utilized in hospital settings, particularly in intensive care units and surgical wards. The device is suitable for adult and pediatric patients requiring long-term venous access.
Indications for Use
The CVC Wand Safety Introducer is indicated for patients needing central venous catheterization. It is particularly useful in situations where minimizing blood loss and preventing air embolism are critical, such as in patients with coagulopathy or those at risk for embolic events.
Practical Considerations
The device is available in various sizes to accommodate different catheter dimensions and patient anatomies. It is compatible with standard central venous catheters and requires familiarity with Seldinger technique for optimal use. Clinicians should ensure proper aseptic technique to prevent infection.
Frequently Asked Questions
What is the CVC Wand Safety Introducer used for?
It is used to facilitate the safe insertion of central venous catheters, minimizing blood loss and air embolism.
What specialties typically use this device?
Interventional radiologists, vascular surgeons, and critical care specialists commonly use this device.
What are the FDA-cleared indications?
The device is indicated for central venous catheterization, particularly in patients where minimizing blood loss and preventing air embolism are important.
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.