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the powerwand safety introducer with and extended dwell
Access Scientific
Summary: The Powerwand Safety Introducer is a medical device used for vascular access, particularly in extended dwell catheter placements. It is commonly used by interventional radiologists and vascular specialists.
FDA Clearance Information
Pathway
510K
Number
K121748 ↗
Decision Date
July 27, 2012
Product Code
DYB
Device Class
Class 2
Evidence
0 studies
The Powerwand Safety Introducer was cleared through the FDA 510(k) pathway on July 27, 2012. Manufactured by Access Scientific, it is classified as a Class 2 device under product code DYB.
What It Is
The Powerwand Safety Introducer is a device designed to facilitate the safe and efficient placement of extended dwell catheters. It incorporates features that minimize the risk of complications such as embolization. The device is particularly useful in ensuring secure vascular access in patients requiring longer-term intravenous therapy.
Clinical Applications
This device is commonly used in settings such as hospitals and outpatient clinics where extended vascular access is required. It is particularly useful in specialties like interventional radiology, oncology, and critical care. The device is suitable for patients who need long-term medication administration, such as chemotherapy or antibiotics.
Indications for Use
The Powerwand Safety Introducer is indicated for use in patients requiring extended vascular access for therapies such as intravenous medications or fluids. It is particularly beneficial for patients who need reliable and safe catheter placement over an extended period.
Practical Considerations
The device is available in various sizes to accommodate different patient anatomies and clinical needs. It is compatible with standard catheter systems and requires familiarity with vascular access techniques for optimal use. Proper training in its use is recommended to ensure safety and efficacy.
Frequently Asked Questions
What is the Powerwand Safety Introducer used for?
It is used for the safe and efficient placement of extended dwell catheters for long-term vascular access.
What specialties typically use this device?
Interventional radiology, oncology, and critical care specialists commonly use this device.
What are the FDA-cleared indications?
The device is indicated for patients requiring extended vascular access for therapies such as intravenous medications or fluids.
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.