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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
510K
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.
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, antibiotics, or total parenteral nutrition. The PICC WAND R is suitable for adult and pediatric patients, providing a reliable method for central venous access.
Indications for Use
The FDA indications for the PICC WAND R include its use in the placement of PICCs, which are necessary for patients needing prolonged intravenous treatments. It is indicated for patients who require central venous access for therapies such as chemotherapy, long-term antibiotics, or nutritional support.
Practical Considerations
The PICC WAND R is available in various sizes to accommodate different patient anatomies and catheter specifications. It is compatible with standard PICC lines and requires sterile technique during insertion. Clinicians should be trained in vascular access procedures to ensure proper use of the device.
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.