đź“‹ FDA Reference
the powerwand safety introducer with an extended dwell catheter
Access Scientific
Summary: The Powerwand Safety Introducer with an Extended Dwell Catheter is a medical device used for vascular access, primarily by clinicians in hospital settings. It is designed to facilitate safe and efficient catheter placement.
FDA Clearance Information
Pathway
510K
Number
K131300 ↗
Decision Date
June 7, 2013
Product Code
DYB
Device Class
Class 2
Evidence
0 studies
The Powerwand Safety Introducer was cleared through the FDA 510(k) pathway on June 7, 2013. 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 assist in the placement of extended dwell catheters, which are used for medium-term vascular access. It incorporates safety features to minimize the risk of complications such as embolism or infection. The device is typically used in settings where reliable venous access is needed for extended periods, such as in patients requiring long-term medication administration or frequent blood draws.
Clinical Applications
This device is commonly used in hospital settings, particularly in departments like oncology, internal medicine, and surgery, where patients may require prolonged intravenous therapy. It is suitable for adult patients who need medium-term vascular access, such as those undergoing chemotherapy or receiving long-term antibiotics. The device helps reduce the need for repeated venipunctures, improving patient comfort and care efficiency.
Indications for Use
The FDA indications for the Powerwand Safety Introducer focus on its use in providing safe and effective vascular access. It is intended for patients who require extended intravenous therapy, reducing the need for frequent needle insertions and minimizing associated risks.
Practical Considerations
The Powerwand Safety Introducer is available in various sizes to accommodate different patient anatomies and clinical needs. It is compatible with standard catheterization techniques and can be used alongside other vascular access devices. Clinicians should be trained in its use to ensure optimal outcomes and patient safety.
Frequently Asked Questions
What is the Powerwand Safety Introducer used for?
It is used for placing extended dwell catheters to provide medium-term vascular access for patients requiring prolonged intravenous therapy.
What specialties typically use this device?
Specialties such as oncology, internal medicine, and surgery commonly use this device for patients needing long-term IV access.
What are the FDA-cleared indications?
The device is indicated for safe and efficient vascular access in patients needing extended intravenous therapy, minimizing the need for repeated needle insertions.
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.