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hemodialysis introducer set
Thomas Medical Products
Summary: The hemodialysis introducer set is a medical device used to facilitate vascular access for hemodialysis. It is primarily used by nephrologists and interventional radiologists in hospital and dialysis center settings.
FDA Clearance Information
Pathway
510K
Number
K961780 ↗
Decision Date
December 24, 1996
Product Code
DYB
Device Class
Class 2
Evidence
0 studies
The hemodialysis introducer set by Thomas Medical Products was cleared through the FDA 510(k) pathway on December 24, 1996. It is a Class 2 device under product code DYB.
What It Is
The hemodialysis introducer set is a sterile, single-use medical device designed to provide vascular access for hemodialysis treatment. It typically includes a sheath, dilator, and guidewire, allowing for the insertion of a dialysis catheter into a central vein. This device is crucial for patients requiring long-term dialysis, ensuring efficient and safe access to the bloodstream.
Clinical Applications
Commonly used in nephrology and interventional radiology, the hemodialysis introducer set is employed in hospital settings and dialysis centers. It is essential for patients with chronic kidney disease who require regular hemodialysis. The device facilitates the placement of a catheter into large veins, such as the internal jugular or subclavian veins, ensuring reliable vascular access.
Indications for Use
The FDA indications suggest this device is used for establishing vascular access in patients needing hemodialysis. It is particularly useful for those with end-stage renal disease or acute kidney injury requiring dialysis.
Practical Considerations
The hemodialysis introducer set comes in various sizes to accommodate different patient anatomies and catheter types. It is compatible with standard dialysis catheters and requires sterile technique during insertion to prevent infection.
Related Literature
The linked study, 'VitaFlowTM II Transcatheter Aortic Valve System Study,' does not directly relate to the hemodialysis introducer set. However, it highlights the importance of vascular access devices in interventional procedures. The study lacks specific findings and limitations due to the absence of an abstract.
Frequently Asked Questions
What is the hemodialysis introducer set used for?
It is used to establish vascular access for hemodialysis treatment in patients with kidney failure.
What specialties typically use this device?
Nephrology and interventional radiology specialists commonly use this device.
What are the FDA-cleared indications?
The device is indicated for creating vascular access for hemodialysis in patients with renal 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.