đź“‹ FDA Reference
the powerwand safety introducer with an extended dwell catheter 3fr model
Access Scientific
Summary: The Powerwand Safety Introducer with an Extended Dwell Catheter 3Fr is a medical device used for vascular access, primarily by clinicians in interventional radiology and vascular surgery. It facilitates the introduction of catheters for extended dwell times.
FDA Clearance Information
Pathway
510K
Number
K162322 ↗
Decision Date
November 17, 2016
Product Code
DYB
Device Class
Class 2
Evidence
0 studies
The Powerwand Safety Introducer was cleared through the FDA 510k pathway on November 17, 2016. It is manufactured by Access Scientific and classified as a Class 2 device under product code DYB.
What It Is
The Powerwand Safety Introducer is a device designed to facilitate the insertion of a catheter into the vascular system. It features a 3Fr extended dwell catheter, allowing for prolonged vascular access. The device is engineered to enhance safety during insertion, reducing the risk of complications such as embolism or infection. Its design supports ease of use and efficiency in clinical settings.
Clinical Applications
This device is commonly used in procedures requiring reliable vascular access, such as administering medications, fluids, or nutrition over extended periods. It is frequently utilized in interventional radiology, vascular surgery, and intensive care settings. The Powerwand is suitable for patients requiring long-term intravenous therapy, including those with chronic conditions or undergoing complex treatments.
Indications for Use
The FDA-cleared indications for this device include providing vascular access for patients needing extended intravenous therapy. It is particularly beneficial for patients who require stable and long-term catheter placement.
Practical Considerations
The Powerwand Safety Introducer is typically available in a 3Fr size, compatible with a range of catheter types. Clinicians should be trained in its insertion technique to minimize complications. The device's design prioritizes safety and ease of use, making it suitable for various clinical environments.
Frequently Asked Questions
What is the Powerwand Safety Introducer used for?
It is used for providing vascular access for extended intravenous therapy.
What specialties typically use this device?
Interventional radiology, vascular surgery, and intensive care specialists commonly use this device.
What are the FDA-cleared indications?
The device is indicated for providing vascular access for patients requiring extended 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.