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truefit bolus trueflex bolus
Adaptiiv Medical Technologies
Summary: The Truefit Bolus Trueflex Bolus by Adaptiiv Medical is a Class 2 medical device used in dialysis access procedures. It is primarily utilized by nephrologists and vascular surgeons to enhance patient outcomes.
FDA Clearance Information
Pathway
510K
Number
K243057 ↗
Decision Date
October 23, 2024
Product Code
MUJ
Device Class
Class 2
Evidence
0 studies
The Truefit Bolus Trueflex Bolus was cleared through the FDA 510k pathway on October 23, 2024. Manufactured by Adaptiiv Medical Technologies, it is classified as a Class 2 device under product code MUJ.
What It Is
The Truefit Bolus Trueflex Bolus is a specialized medical device designed to optimize dialysis access procedures. It works by providing a flexible and adaptable interface that can be customized to fit the unique anatomical needs of each patient. This device enhances the precision and effectiveness of vascular access, which is critical for patients undergoing regular dialysis.
Clinical Applications
This device is commonly used in clinical settings where dialysis access is required, such as nephrology clinics and hospitals. It is particularly beneficial for patients with complex vascular anatomy or those who have had previous access complications. Nephrologists and vascular surgeons use this device to improve the quality and longevity of dialysis access, ultimately enhancing patient care.
Indications for Use
The FDA-cleared indications for the Truefit Bolus Trueflex Bolus involve its use in creating and maintaining vascular access for dialysis patients. It is intended for patients who require reliable and efficient access to their bloodstream for dialysis treatment.
Practical Considerations
The Truefit Bolus Trueflex Bolus is available in various sizes to accommodate different patient anatomies. It is compatible with standard dialysis equipment and requires careful handling to ensure proper placement and function. Clinicians should be familiar with the device's flexibility and adaptability features to maximize its benefits.
Frequently Asked Questions
What is Truefit Bolus Trueflex Bolus used for?
It is used to create and maintain vascular access for dialysis patients, ensuring efficient and reliable treatment.
What specialties typically use this device?
Nephrologists and vascular surgeons typically use this device in dialysis and vascular access procedures.
What are the FDA-cleared indications?
The device is indicated for use in patients requiring vascular access for dialysis treatment.
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.