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 ?
510(k)
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.
FDA-Cleared Indications
- Establishing peripheral venous access with an extended dwell catheter.
- Administration of intravenous fluids and medications through peripheral venous access.
- Obtaining blood samples through the indwelling catheter when clinically appropriate.
Clinical Applications
- Medium-term peripheral intravenous access in hospitalized patients.
- Intravenous medication or fluid administration when repeated venipuncture would otherwise be needed.
- Blood sampling through an appropriately placed extended dwell catheter.
- Vascular access using standard catheter-placement techniques under trained clinician supervision.
Practical Considerations
- The device is available in different catheter and introducer configurations; the selected size should match the patient's vein, prescribed therapy, and clinical requirements.
- Placement should be performed by trained clinicians using appropriate aseptic technique and institutional vascular-access protocols.
- The catheter should be inspected and managed according to the manufacturer's instructions and local policies for dressing changes, flushing, patency, and removal.
- MRI compatibility depends on the specific catheter and introducer configuration and the manufacturer's current labeling; verify the model before an MRI examination.
- Usual peripheral intravenous contraindications and precautions apply, including infection at the insertion site, unsuitable veins, and therapies that require central venous access.
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.