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panther realart model 4 7
Prowess
Summary: The Panther RealART Model 4 7 by Prowess is a Class 2 medical device used in dialysis access procedures. It is primarily utilized by nephrologists and vascular surgeons to facilitate effective dialysis treatment.
FDA Clearance Information
Pathway
510K
Number
K083502 ↗
Decision Date
May 5, 2009
Product Code
MUJ
Device Class
Class 2
Evidence
0 studies
The Panther RealART Model 4 7 was cleared through the FDA 510(k) pathway on May 5, 2009. Manufactured by Prowess, this device is classified as Class 2 under product code MUJ.
What It Is
The Panther RealART Model 4 7 is a dialysis access device designed to assist in the creation and maintenance of vascular access for hemodialysis. It works by providing a reliable means to connect dialysis machines to the patient's bloodstream, ensuring efficient blood filtration. This device is crucial for patients requiring long-term dialysis, as it helps maintain the integrity and functionality of the access site.
Clinical Applications
Commonly used in nephrology and vascular surgery, this device is essential in settings where patients undergo regular hemodialysis. It is particularly useful in hospital dialysis units and outpatient dialysis centers. The Panther RealART Model 4 7 is suitable for patients with chronic kidney disease who require consistent and reliable vascular access for their dialysis treatments.
Indications for Use
The FDA indications for this device involve its use in creating and maintaining vascular access for dialysis patients. It is intended for individuals with end-stage renal disease who need regular hemodialysis.
Practical Considerations
When using the Panther RealART Model 4 7, clinicians should consider the appropriate sizing to match the patient's vascular anatomy. Compatibility with standard dialysis equipment is generally expected, but verification with specific machines is advisable. Proper technique in insertion and maintenance is crucial to prevent complications.
Frequently Asked Questions
What is Panther RealART Model 4 7 used for?
It is used to create and maintain vascular access for patients undergoing hemodialysis.
What specialties typically use this device?
Nephrologists and vascular surgeons typically use this device in dialysis settings.
What are the FDA-cleared indications?
The device is indicated for creating and maintaining vascular access in patients requiring hemodialysis.
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.