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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
510K
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.
Clinical Applications
This device is commonly used in hospital settings, particularly in interventional radiology and vascular access departments. It is utilized for patients requiring long-term intravenous therapy, such as chemotherapy or antibiotic administration. The device is suitable for adult and pediatric patients who need reliable central venous access.
Indications for Use
The FDA indications for the PICC Wand Peelable Safety Introducer include its use in the placement of PICCs for patients who require central venous access. It is indicated for patients with conditions necessitating prolonged intravenous therapy.
Practical Considerations
The device is available in various sizes to accommodate different patient anatomies and catheter sizes. It is compatible with standard PICCs and requires aseptic technique during insertion. Clinicians should be trained in its use to ensure optimal outcomes.
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.