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alta lr fixed tip chronic hemodialysis catheter models al19nh24 al23nh28 al27nh32 al31nh36 al35nh40
Spire Biomedical
Summary: The Alta LR Fixed Tip Chronic Hemodialysis Catheter is used for long-term hemodialysis access. It is primarily utilized by nephrologists and vascular surgeons in patients requiring chronic dialysis.
FDA Clearance Information
Pathway
510K
Number
K040509 ↗
Decision Date
April 19, 2004
Product Code
MSD
Device Class
Class 2
Evidence
0 studies
The Alta LR Fixed Tip Catheter by Spire Biomedical was cleared through the FDA 510(k) pathway on April 19, 2004. It is classified as a Class 2 medical device under product code MSD.
What It Is
The Alta LR Fixed Tip Chronic Hemodialysis Catheter is a vascular access device designed for long-term hemodialysis. It features a fixed tip to facilitate stable positioning within the vascular system, ensuring effective blood flow during dialysis sessions. The catheter is inserted into a central vein, typically the internal jugular or subclavian vein, and provides a reliable conduit for blood exchange between the patient and the dialysis machine.
Clinical Applications
This catheter is commonly used in patients with end-stage renal disease who require regular hemodialysis. It is typically placed in hospital settings or specialized dialysis centers by nephrologists or interventional radiologists. The device is suitable for adult and pediatric patients who need long-term vascular access due to chronic kidney failure.
Indications for Use
The FDA-cleared indications for this catheter include providing vascular access for patients undergoing chronic hemodialysis. It is intended for use in individuals who require long-term dialysis treatment due to kidney failure.
Practical Considerations
The Alta LR Fixed Tip Catheter comes in various sizes to accommodate different patient anatomies, with lengths ranging from 19 cm to 35 cm. It is compatible with standard dialysis equipment and requires careful insertion technique to minimize complications such as infection or thrombosis.
Frequently Asked Questions
What is the Alta LR Fixed Tip Catheter used for?
It is used for providing long-term vascular access in patients undergoing chronic hemodialysis.
What specialties typically use this device?
Nephrologists, vascular surgeons, and interventional radiologists typically use this device.
What are the FDA-cleared indications?
The catheter is indicated for providing vascular access for chronic hemodialysis in patients with 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.