đź“‹ FDA Reference
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 ?
510(k)
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.
FDA-Cleared Indications
- For use as an introducer during placement of central venous catheters.
- For percutaneous access to the central venous system when a central venous catheter is indicated.
Clinical Applications
- Introducing central venous catheters through percutaneous central venous access.
- Facilitating placement of central venous catheters for infusion of medications or other intravenous therapies.
- Facilitating placement of central venous catheters used for hemodynamic monitoring.
- Facilitating placement of central venous catheters used for renal replacement therapy or dialysis when the catheter and introducer size are compatible.
Practical Considerations
- The appropriate sheath size should match the intended central venous catheter and the patient's anatomy.
- Use requires standard central-line insertion skills, sterile technique, vascular access equipment and appropriate imaging guidance when indicated.
- The valve and peelable sheath should be handled according to the manufacturer's instructions to reduce blood loss, air entry and contamination.
- The device is an introducer and is not itself a long-term indwelling catheter; the catheter remains in place after the sheath is removed.
- MRI safety should be confirmed in the current manufacturer labeling before scanning. Do not assume MRI compatibility from the device name alone.
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.