đź“‹ FDA Reference
the powerwand r safety introducer with an extended dwell catheter
Access Scientific
Summary: The Powerwand R Safety Introducer with an Extended Dwell Catheter is a medical device used for vascular access procedures. It is typically utilized by clinicians in settings requiring reliable and extended vascular access.
FDA Clearance Information
Pathway
510K
Number
K111417 ↗
Decision Date
July 15, 2011
Product Code
DYB
Device Class
Class 2
Evidence
0 studies
The Powerwand R Safety Introducer was cleared through the FDA 510k pathway on July 15, 2011. It is manufactured by Access Scientific and is classified as a Class 2 device under product code DYB.
What It Is
The Powerwand R Safety Introducer is a vascular access device designed to facilitate the insertion of an extended dwell catheter. It provides a safe and efficient method for establishing vascular access, minimizing the risk of complications associated with traditional methods. The device is engineered to enhance patient comfort and reduce the likelihood of infection.
Clinical Applications
This device is commonly used in clinical scenarios requiring extended vascular access, such as in patients needing long-term medication administration, fluid therapy, or nutritional support. It is particularly useful in hospital settings, outpatient clinics, and home care environments. Specialties that frequently use this device include internal medicine, oncology, and critical care.
Indications for Use
The Powerwand R Safety Introducer is indicated for patients who require extended vascular access. It is suitable for conditions where prolonged intravenous therapy is necessary, such as chronic illnesses requiring regular medication or fluid administration.
Practical Considerations
The device typically comes in various sizes to accommodate different patient needs and anatomical considerations. It is compatible with standard vascular access techniques and can be integrated into existing clinical workflows with minimal disruption. Proper training in insertion techniques is recommended to maximize safety and efficacy.
Frequently Asked Questions
What is the Powerwand R Safety Introducer used for?
It is used for establishing extended vascular access in patients requiring long-term intravenous therapy.
What specialties typically use this device?
Specialties such as internal medicine, oncology, and critical care frequently use this device.
What are the FDA-cleared indications?
The device is indicated for patients needing extended vascular access for prolonged 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.