📋 FDA Reference
The PICC Wand Peelable Safety Introducer
Access Scientific
Summary: The PICC Wand Peelable Safety Introducer is a medical device used for the safe and efficient placement of peripherally inserted central catheters (PICCs). It is typically used by interventional radiologists and specialized nursing staff.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K093022 ↗
Decision Date ?
January 20, 2010
Product Code ?
DYB
Device Class ?
Class 2
Evidence ?
0 studies
The PICC Wand Peelable Safety Introducer was cleared through the FDA 510(k) pathway on January 20, 2010. Manufactured by Access Scientific, it is classified as a Class 2 device under product code DYB.
What It Is
The PICC Wand Peelable Safety Introducer is a device designed to facilitate the insertion of PICCs. It features a peelable sheath that allows for the safe introduction of the catheter into the central venous system. This device enhances safety by minimizing the risk of catheter-related complications during insertion.
FDA-Cleared Indications
- Placement of peripherally inserted central catheters (PICCs).
- Use as a peelable safety introducer during PICC insertion for patients requiring central venous access.
Clinical Applications
- Introducing a PICC through a peripheral vein toward the central venous system.
- Supporting placement of central venous access for prolonged intravenous therapy.
- Use with compatible PICCs in hospital vascular access and interventional radiology settings.
- PICC placement in appropriately selected adult or pediatric patients when central venous access is needed.
Practical Considerations
- The introducer must be matched to the size and design of the PICC being placed; available sizes and compatibility should be confirmed in the product instructions.
- Use requires sterile or aseptic technique and training in PICC placement, guidewire handling and peelable-sheath removal.
- The device is intended to facilitate PICC placement and is not itself a long-term vascular access catheter.
- MRI safety depends on the introducer components and whether any device remains in the patient; consult the current labeling before MRI. A removed introducer does not create an ongoing MRI concern.
- Potential complications are primarily related to vascular access and PICC placement, including bleeding, infection, vessel injury, thrombosis, malposition and catheter-related complications.
Frequently Asked Questions
What is the PICC Wand Peelable Safety Introducer used for?
It is used for the safe and efficient placement of peripherally inserted central catheters (PICCs) in patients requiring central venous access.
What specialties typically use this device?
Interventional radiologists and specialized nursing staff in vascular access departments typically use this device.
What are the FDA-cleared indications?
The device is indicated for the placement of PICCs in patients needing central venous access for prolonged intravenous therapy.
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.