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velcro fistula pressure clamps
Cp Medical
Summary: Velcro fistula pressure clamps are used to control bleeding from dialysis access sites. They are primarily used by nephrologists and dialysis nurses in clinical settings.
FDA Clearance Information
Pathway
510K
Number
K853536 ↗
Decision Date
October 17, 1985
Product Code
KXM
Device Class
Class 2
Evidence
0 studies
The velcro fistula pressure clamps were cleared through the FDA 510(k) pathway on October 17, 1985. Manufactured by Cp Medical, this device is classified as Class 2 under product code KXM.
What It Is
Velcro fistula pressure clamps are medical devices designed to apply pressure to arteriovenous fistulas or grafts, commonly used in dialysis patients. The device utilizes a velcro mechanism to secure the clamp in place, allowing for adjustable pressure application. This helps in achieving hemostasis after needle removal from dialysis access sites, reducing the risk of bleeding and hematoma formation.
Clinical Applications
These clamps are commonly used in dialysis centers and hospitals where hemodialysis is performed. Nephrologists and dialysis nurses use them to manage vascular access sites in patients undergoing dialysis. The device is particularly useful in patients with difficult-to-control bleeding or those on anticoagulation therapy, ensuring safe and effective post-dialysis care.
Indications for Use
The device is indicated for use in patients with arteriovenous fistulas or grafts, primarily those receiving hemodialysis. It is designed to help control bleeding at the access site after dialysis sessions.
Practical Considerations
Velcro fistula pressure clamps come in various sizes to accommodate different patient needs and access site locations. They are compatible with standard dialysis procedures and require minimal training for effective use. Clinicians should ensure proper placement and pressure to avoid complications.
Frequently Asked Questions
What is velcro fistula pressure clamps used for?
They are used to control bleeding from dialysis access sites after needle removal.
What specialties typically use this device?
Nephrology and dialysis nursing specialties commonly use this device.
What are the FDA-cleared indications?
The device is indicated for controlling bleeding at arteriovenous fistula or graft sites in dialysis patients.
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.