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prowess panther proarc model version 5 0
Prowess
Summary: The Prowess Panther ProArc Model Version 5.0 is a dialysis access device used primarily by nephrologists and vascular surgeons to facilitate hemodialysis in patients with renal failure. It is designed for efficient vascular access management.
FDA Clearance Information
Pathway
510K
Number
K101076 ↗
Decision Date
July 27, 2010
Product Code
MUJ
Device Class
Class 2
Evidence
0 studies
The Prowess Panther ProArc Model Version 5.0 was cleared through the FDA 510(k) pathway on July 27, 2010. Manufactured by Prowess, it is classified as a Class 2 device under product code MUJ.
What It Is
The Prowess Panther ProArc Model Version 5.0 is a medical device designed to provide reliable vascular access for patients undergoing hemodialysis. It typically consists of a catheter system that is inserted into a central vein, allowing for efficient blood flow during dialysis sessions. The device is engineered to minimize complications such as infections and thrombosis, which are common concerns in dialysis access management.
Clinical Applications
This device is commonly used in nephrology and vascular surgery settings, particularly in hospitals and dialysis centers. It is essential for patients with chronic kidney disease requiring regular hemodialysis. The device is used to establish and maintain vascular access, a critical component of effective dialysis treatment, ensuring that patients receive adequate blood purification.
Indications for Use
The Prowess Panther ProArc Model Version 5.0 is indicated for patients who need vascular access for hemodialysis. This includes individuals with end-stage renal disease or chronic kidney failure who require long-term dialysis treatment.
Practical Considerations
The device comes in various sizes to accommodate different patient anatomies and is compatible with standard dialysis equipment. Clinicians should be trained in catheter insertion techniques to minimize complications. Regular monitoring and maintenance are crucial to ensure device longevity and patient safety.
Frequently Asked Questions
What is the Prowess Panther ProArc Model Version 5.0 used for?
It is used to provide vascular access for patients undergoing hemodialysis.
What specialties typically use this device?
Nephrologists and vascular surgeons typically use this device in dialysis centers and hospitals.
What are the FDA-cleared indications?
The device is indicated for providing vascular access in patients requiring hemodialysis, such as those with chronic kidney failure.
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.