📋 FDA Reference
PICC Wand Peelable Safety Introducer
Access Scientific
Summary: The PICC Wand Peelable Safety Introducer is a medical device used for the insertion of peripherally inserted central catheters (PICC lines). It is primarily used by interventional radiologists and vascular access specialists to facilitate safe and efficient catheter placement.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K101150 ↗
Decision Date ?
August 13, 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 August 13, 2010. Manufactured by Access Scientific, this device is classified as a Class 2 medical device under product code DYB.
What It Is
The PICC Wand Peelable Safety Introducer is designed to aid in the insertion of PICC lines by providing a peelable sheath that simplifies the process. It integrates a safety mechanism to minimize the risk of needle-stick injuries, enhancing safety for both patients and healthcare providers. The device is particularly useful in settings where central venous access is required for long-term intravenous therapy.
FDA-Cleared Indications
- Use in the insertion of peripherally inserted central catheters (PICCs).
Clinical Applications
- Facilitating PICC placement for extended intravenous medication therapy.
- Facilitating PICC placement for patients receiving long-term chemotherapy.
- Facilitating PICC placement for extended antibiotic treatment.
- Facilitating PICC placement for total parenteral nutrition.
Practical Considerations
- The introducer is available in different sizes; the selected size must match the PICC and the patient's vascular anatomy.
- Use requires sterile technique and appropriate training in introducer and PICC placement, commonly with ultrasound guidance.
- The peelable sheath is designed to be split and removed after the catheter is positioned; it is not intended to remain as a long-term implant.
- MRI safety depends on the specific PICC and any retained components used with the system. Confirm the current device labeling before MRI.
- Contraindications, precautions, and compatibility should be checked in the manufacturer's current instructions for use.
Frequently Asked Questions
What is the PICC Wand Peelable Safety Introducer used for?
It is used for the insertion of peripherally inserted central catheters (PICC lines) to provide long-term intravenous access.
What specialties typically use this device?
Interventional radiologists, vascular access specialists, and specialized nursing staff commonly use this device.
What are the FDA-cleared indications?
The device is indicated for the insertion of PICC lines in patients requiring long-term central venous access.
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.