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blom-singer adjustable bi-fianged fistula prosthesis
Helix Medical
Summary: The Blom-Singer Adjustable Bi-Flanged Fistula Prosthesis is a medical device used in dialysis access. It is primarily utilized by nephrologists and vascular surgeons to maintain or establish vascular access in patients undergoing dialysis.
FDA Clearance Information
Pathway
510K
Number
K130736 ↗
Decision Date
December 17, 2013
Product Code
LRC
Device Class
Class 1
Evidence
0 studies
The Blom-Singer Adjustable Bi-Flanged Fistula Prosthesis was cleared via the FDA 510k pathway on December 17, 2013. Manufactured by Helix Medical, it is classified as a Class 1 device under product code LRC.
What It Is
The Blom-Singer Adjustable Bi-Flanged Fistula Prosthesis is designed to facilitate vascular access for dialysis patients. It features an adjustable bi-flanged design that helps secure the prosthesis in place, reducing the risk of dislodgement. This device is particularly useful in maintaining long-term access for hemodialysis, ensuring efficient blood flow and minimizing complications.
Clinical Applications
This prosthesis is commonly used in nephrology and vascular surgery settings, particularly in patients requiring long-term dialysis. It is suitable for use in both hospital and outpatient settings, providing a reliable option for patients with challenging vascular access. The device is often employed in patients with end-stage renal disease who require consistent and reliable access for their dialysis treatments.
Indications for Use
The FDA-cleared indications suggest that this device is intended for patients who need vascular access for dialysis. It is particularly useful for those who have difficulty maintaining traditional fistula access due to anatomical or physiological challenges.
Practical Considerations
The prosthesis comes in various sizes to accommodate different patient anatomies. It is compatible with standard dialysis equipment, and clinicians should ensure proper sizing and placement to optimize function and reduce the risk of complications. Familiarity with vascular access techniques is essential for successful implementation.
Frequently Asked Questions
What is the Blom-Singer Adjustable Bi-Flanged Fistula Prosthesis used for?
It is used to establish and maintain vascular access for patients undergoing dialysis, particularly in those with challenging access needs.
What specialties typically use this device?
Nephrologists and vascular surgeons typically use this device in both hospital and outpatient settings.
What are the FDA-cleared indications?
The device is indicated for use in patients requiring vascular access for dialysis, especially those with difficult-to-maintain traditional fistula access.
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.