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acqplan 5 0
Philips Medical Systems
Summary: The acqplan 5 0, by Philips Medical Systems, is a Class 2 medical device used in dialysis access procedures. It is primarily utilized by nephrologists and interventional radiologists.
FDA Clearance Information
Pathway
510K
Number
K013644 ↗
Decision Date
September 12, 2002
Product Code
MUJ
Device Class
Class 2
Evidence
0 studies
The acqplan 5 0 was cleared through the FDA 510k pathway on September 12, 2002. Manufactured by Philips Medical Systems, it is classified as a Class 2 device under product code MUJ.
What It Is
The acqplan 5 0 is a medical device designed to assist in the planning and execution of dialysis access procedures. It integrates imaging and procedural planning to optimize vascular access for dialysis patients. The device enhances precision in creating and maintaining access sites, which are crucial for effective dialysis treatment.
Clinical Applications
This device is commonly used in settings where dialysis access is established or maintained, such as hospitals and specialized dialysis centers. Nephrologists and interventional radiologists frequently use it to plan and guide procedures for patients requiring long-term dialysis. It is particularly beneficial in complex cases where precise vascular access is critical.
Indications for Use
The acqplan 5 0 is indicated for use in patients requiring vascular access for dialysis. It is suitable for individuals with chronic kidney disease who need reliable and efficient access for hemodialysis treatments.
Practical Considerations
Clinicians should consider the compatibility of the acqplan 5 0 with existing imaging systems. The device is typically used in conjunction with ultrasound or fluoroscopy to enhance visualization during procedures. Proper training in its use can improve outcomes and reduce procedural complications.
Frequently Asked Questions
What is acqplan 5 0 used for?
The acqplan 5 0 is used for planning and guiding dialysis access procedures, ensuring precise vascular access for hemodialysis.
What specialties typically use this device?
Nephrologists and interventional radiologists typically use the acqplan 5 0 in dialysis centers and hospitals.
What are the FDA-cleared indications?
The device is indicated for use in establishing and maintaining vascular access for patients undergoing dialysis.
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.