đź“‹ FDA Reference
the powerwand safety introducer with an extended dwell catheter made of chronoflex c r with bioguard technology-3 fr 4 fr and 5 fr model
Access Scientific
Summary: The Powerwand Safety Introducer is a medical device used for vascular access, primarily by clinicians in interventional radiology and vascular surgery. It is designed to facilitate the introduction of catheters with enhanced safety features.
FDA Clearance Information
Pathway
510K
Number
K183066 ↗
Decision Date
July 25, 2019
Product Code
DYB
Device Class
Class 2
Evidence
0 studies
The Powerwand Safety Introducer was cleared through the FDA 510(k) pathway on July 25, 2019. 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 used to introduce extended dwell catheters into the vascular system. Made of ChronoFlex C R with BioGuard technology, it is designed to reduce infection risk and improve patient outcomes. The device comes in 3 FR, 4 FR, and 5 FR sizes, allowing for flexibility in different clinical scenarios.
Clinical Applications
This device is commonly used in procedures requiring vascular access, such as the administration of medications, fluids, or nutrition. It is particularly useful in interventional radiology and vascular surgery settings. The Powerwand is suitable for patients needing extended catheterization, including those in intensive care or undergoing long-term treatments.
Indications for Use
The FDA indications suggest that the Powerwand Safety Introducer is intended for patients requiring vascular access for therapeutic or diagnostic purposes. It is suitable for use in patients who need reliable and safe catheter placement.
Practical Considerations
The Powerwand comes in multiple sizes (3 FR, 4 FR, and 5 FR), making it adaptable for various patient needs. It is compatible with standard vascular access techniques and is designed to minimize infection risks. Clinicians should be familiar with its safety features to maximize its benefits.
Frequently Asked Questions
What is the Powerwand Safety Introducer used for?
It is used for introducing catheters into the vascular system, providing safe and reliable access for therapeutic or diagnostic purposes.
What specialties typically use this device?
Interventional radiology, vascular surgery, and critical care specialists commonly use this device.
What are the FDA-cleared indications?
The device is indicated for patients requiring vascular access for therapeutic or diagnostic purposes, ensuring safe catheter placement.
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.