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14 fr hemodialysis two-lumen catheterization kit
Arrow Intl.
Summary: The 14 Fr hemodialysis two-lumen catheterization kit by Arrow Intl. is used for vascular access in hemodialysis. It is typically used by nephrologists and other healthcare professionals in dialysis centers or hospitals.
FDA Clearance Information
Pathway
510K
Number
K991431 ↗
Decision Date
May 26, 1999
Product Code
MPB
Device Class
Class 2
Evidence
0 studies
The device was cleared through the FDA's 510(k) pathway on May 26, 1999. It is manufactured by Arrow Intl. and classified as a Class 2 medical device under product code MPB.
What It Is
The 14 Fr hemodialysis two-lumen catheterization kit is designed for temporary vascular access in patients requiring hemodialysis. It consists of a catheter with two lumens, allowing for simultaneous blood withdrawal and return. This device is inserted into a large central vein, typically the internal jugular, subclavian, or femoral vein, to facilitate efficient dialysis treatment.
Clinical Applications
This catheter is commonly used in acute settings where immediate hemodialysis is necessary, such as in patients with acute kidney injury or those awaiting permanent dialysis access. It is primarily used by nephrologists and interventional radiologists in hospital settings. The device is suitable for adult patients who require short-term dialysis access.
Indications for Use
The catheter is indicated for patients who need temporary vascular access for hemodialysis, such as those with acute kidney failure or those who have not yet established permanent access like an AV fistula or graft.
Practical Considerations
The 14 Fr size is typical for adult patients and provides adequate flow rates for effective dialysis. Clinicians should ensure proper aseptic technique during insertion to minimize infection risk. Compatibility with dialysis machines and other equipment should be verified prior to use.
Frequently Asked Questions
What is the 14 Fr hemodialysis catheter used for?
It is used for temporary vascular access in patients needing hemodialysis.
What specialties typically use this device?
Nephrologists and interventional radiologists commonly use this device in hospital and dialysis center settings.
What are the FDA-cleared indications?
The catheter is indicated for temporary vascular access in patients requiring hemodialysis.
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.