📋 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 to facilitate the safe insertion of central venous catheters. It is primarily used by interventional radiologists and vascular surgeons.
FDA Clearance Information
Pathway ?
510(k)
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.
FDA-Cleared Indications
- Facilitate the introduction of central venous catheters into the vascular system.
- Provide access for central venous catheter placement using a peelable sheath.
- The device is intended for use with compatible central venous catheters according to the manufacturer's labeling.
Clinical Applications
- Placement of central venous catheters for administration of chemotherapy.
- Placement of central venous catheters for hemodialysis access.
- Placement of central venous catheters for parenteral nutrition.
- Central venous catheter placement in hospital and procedural settings when a peelable, valved introducer is appropriate.
Practical Considerations
- The introducer is used with the Seldinger technique and should be placed with appropriate imaging and sterile technique.
- Available sizes should be matched to the intended catheter and the patient's venous anatomy; clinicians should verify compatibility in the current instructions for use.
- The peelable sheath is designed to be split and removed after catheter advancement. The valve may help limit blood loss and air entry, but it does not eliminate those risks.
- MRI safety and conditional-use information should be confirmed in the current manufacturer labeling; this FDA record alone does not establish that the device is MR Safe or MR Conditional.
- Contraindications and precautions include local or systemic infection, significant bleeding risk, thrombosis or obstruction of the intended vein, and inability to maintain sterile technique. The complete labeling should be reviewed before use.
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.