đź“‹ FDA Reference
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 ?
510(k)
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.
FDA-Cleared Indications
- Vascular access for hemodialysis.
Clinical Applications
- Providing vascular access during hemodialysis.
- Connecting a patient’s vascular system to standard dialysis equipment for blood removal and return.
- Use in patients who require hemodialysis for renal failure, when the device configuration is appropriate for the clinical situation.
Practical Considerations
- The available FDA summary does not provide details about catheter length, diameter, lumens, tip configuration, or intended duration of use; clinicians should consult the current labeling.
- Placement and management require trained clinicians and appropriate imaging or procedural guidance based on the access site and patient anatomy.
- The device must be compatible with the dialysis circuit and accessories used by the treating facility.
- Potential vascular-access complications include infection, thrombosis, bleeding, malposition, and vessel injury.
- MRI safety, conditional-use requirements, and contraindications are not established by the information provided here; check the manufacturer’s current instructions before MRI or use in special patient populations.
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.