📋 FDA Reference
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 ?
510(k)
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.
FDA-Cleared Indications
- Use in procedures involving vascular access for hemodialysis.
- Use to support the planning, creation, or maintenance of dialysis access, as described by the applicable FDA labeling.
Clinical Applications
- Planning vascular access for patients who require hemodialysis.
- Supporting procedures to establish dialysis access.
- Supporting procedures to evaluate or maintain existing dialysis access.
- Use in hospitals, interventional radiology departments, and dialysis-care settings when performing labeled dialysis-access procedures.
Practical Considerations
- Confirm the current Philips labeling and the specific configuration before use; the abbreviated device name does not provide enough information to determine exact dimensions or accessories.
- Compatibility with the facility's imaging system should be verified before a procedure.
- Ultrasound and fluoroscopy may be used when appropriate for visualization and procedural guidance, but the imaging method depends on the procedure and device configuration.
- MRI safety cannot be determined from the available FDA record. Review the manufacturer's MRI labeling before bringing any component into the MRI environment.
- Use should be limited to trained clinicians following the manufacturer's instructions, applicable dialysis-access guidelines, and patient-specific contraindications.
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.