📋 FDA Reference
Acute Hemodialysis Tray Cat 09-9540-7
Med-West
Summary: The acute hemodialysis tray cat 09-9540-7 is a medical device used for hemodialysis procedures, primarily by nephrologists and dialysis nurses. It facilitates vascular access for patients requiring acute dialysis treatment.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K854612 ↗
Decision Date ?
January 3, 1986
Product Code ?
LFK
Device Class ?
Class 2
Evidence ?
0 studies
The device was cleared through the FDA 510k pathway on January 3, 1986, by Med-West. It is classified as a Class 2 device under product code LFK.
What It Is
The acute hemodialysis tray cat 09-9540-7 is a pre-packaged kit designed to assist in the setup and execution of hemodialysis procedures. It typically includes components necessary for establishing vascular access, such as catheters and sterile drapes. This device is essential in providing efficient and sterile conditions for acute dialysis treatment, ensuring patient safety and procedural efficacy.
FDA-Cleared Indications
- Temporary vascular access for patients who require acute hemodialysis.
- Use in hospital or critical-care settings when dialysis must be initiated urgently.
- Use by trained healthcare professionals according to the device labeling and institutional protocols.
Clinical Applications
- Establishing temporary vascular access for acute hemodialysis.
- Supporting dialysis access in patients with acute kidney failure.
- Supporting urgent dialysis when severe electrolyte, acid-base, or fluid abnormalities require extracorporeal treatment.
- Providing a sterile, organized set of supplies for catheter placement and acute dialysis setup.
Practical Considerations
- The catheter size and length should be selected for the patient's anatomy, access site, prescribed blood-flow requirements, and dialysis-machine compatibility.
- Placement should use sterile technique and appropriate imaging or bedside guidance according to institutional practice; common access vessels include the internal jugular or femoral veins.
- Inspect the package before use and follow the manufacturer's instructions for assembly, flushing, connection, and catheter care.
- This record does not establish MRI safety. MRI conditions should be confirmed from the current device labeling and the exact catheter components before scanning.
- Potential complications include bleeding, arterial puncture, infection, thrombosis, malposition, venous stenosis, air embolism, and catheter dysfunction. Patient-specific contraindications and access-site limitations should be assessed before placement.
Frequently Asked Questions
What is the acute hemodialysis tray cat 09-9540-7 used for?
It is used for establishing vascular access in patients requiring acute hemodialysis.
What specialties typically use this device?
Nephrologists, dialysis nurses, and interventional radiologists commonly use this device.
What are the FDA-cleared indications?
The device is indicated for patients needing acute hemodialysis, such as those with sudden 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.