đź“‹ FDA Reference
the power wand safety introducer with an extended dwell catheter
Access Scientific
Summary: The Power Wand Safety Introducer with an Extended Dwell Catheter is a medical device used for vascular access, primarily by clinicians in settings requiring extended catheterization. It is designed to improve safety and efficiency in catheter placement.
FDA Clearance Information
Pathway
510K
Number
K101422 ↗
Decision Date
March 22, 2011
Product Code
DYB
Device Class
Class 2
Evidence
0 studies
The Power Wand Safety Introducer was cleared through the FDA 510(k) pathway on March 22, 2011. Manufactured by Access Scientific, it is classified as a Class 2 device under product code DYB.
What It Is
The Power Wand Safety Introducer is a medical device designed for vascular access, featuring an extended dwell catheter. It is intended to facilitate safe and efficient placement of catheters in patients requiring extended intravenous therapy. The device incorporates safety features to minimize the risk of complications during insertion.
Clinical Applications
This device is commonly used in clinical settings such as hospitals and outpatient clinics where patients require extended intravenous access, such as for long-term medication administration or nutrition. It is particularly useful in specialties like oncology, critical care, and surgery. The Power Wand is suitable for adult patients who need reliable and safe vascular access.
Indications for Use
The FDA indications suggest that this device is intended for patients who need extended intravenous access. It is particularly beneficial for those requiring long-term treatments, such as chemotherapy or parenteral nutrition.
Practical Considerations
The Power Wand Safety Introducer is available in various sizes to accommodate different patient needs. It is compatible with standard vascular access techniques and requires proper training for insertion to ensure safety and efficacy. Clinicians should be aware of the device's compatibility with other intravenous equipment.
Frequently Asked Questions
What is the Power Wand Safety Introducer used for?
It is used for providing extended intravenous access in patients requiring long-term catheterization.
What specialties typically use this device?
Specialties such as oncology, critical care, and surgery commonly use this device for vascular access.
What are the FDA-cleared indications?
The device is indicated for patients needing extended intravenous access, such as those undergoing long-term treatments.
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.