📋 FDA Reference
The PICC Wand R Peelable Safety Introducer
Access Scientific
Summary: The PICC WAND R Peelable Safety Introducer is a medical device used for the safe and efficient placement of peripherally inserted central catheters (PICCs). It is primarily used by interventional radiologists and vascular access specialists.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K111138 ↗
Decision Date ?
June 22, 2011
Product Code ?
DYB
Device Class ?
Class 2
Evidence ?
0 studies
The PICC WAND R Peelable Safety Introducer by Access Scientific was cleared through the FDA 510k pathway on June 22, 2011. It is classified as a Class 2 device under product code DYB.
What It Is
The PICC WAND R Peelable Safety Introducer is a specialized medical device designed to facilitate the insertion of peripherally inserted central catheters (PICCs). It features a peelable sheath that allows for safe and efficient catheter placement while minimizing the risk of complications. This device is particularly useful in reducing the risk of infection and mechanical complications during PICC insertion.
FDA-Cleared Indications
- Used to facilitate the placement of peripherally inserted central catheters.
- Intended for vascular access procedures requiring introduction and placement of a PICC.
Clinical Applications
- Placement of PICCs for prolonged intravenous antibiotic therapy.
- Placement of PICCs for chemotherapy and other intravenous oncology treatments.
- Placement of PICCs for parenteral nutrition.
- Placement of PICCs when central venous access is needed for extended inpatient or outpatient treatment.
Practical Considerations
- The introducer should be selected in a size compatible with the PICC and the patient's anatomy.
- Use requires sterile technique and clinician training in PICC or vascular access procedures.
- The sheath is peelable and is removed after the catheter has been advanced into position; it is not intended to remain as an indwelling device.
- MRI safety depends on the specific device materials and labeling for the selected product configuration. Confirm the current manufacturer instructions before an MRI examination.
- Contraindications, warnings, and limitations should be reviewed in the current manufacturer instructions for use. The device should not be used if its packaging is damaged or sterility is compromised.
Frequently Asked Questions
What is The PICC WAND R Peelable Safety Introducer used for?
It is used for the safe and efficient placement of peripherally inserted central catheters (PICCs).
What specialties typically use this device?
Interventional radiologists and vascular access specialists commonly use this device.
What are the FDA-cleared indications?
The device is indicated for the placement of PICCs in patients requiring long-term 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.