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hemodialysis cannula femoral clamp
Rodell Medical
Summary: The hemodialysis cannula femoral clamp by Rodell Medical is a device used in dialysis access. It is FDA 510k cleared. Current evidence includes two studies, with limited direct outcomes or safety data reported.
FDA Clearance Information
Pathway
510K
Number
K760973 ↗
Decision Date
January 12, 1977
Product Code
FIQ
Device Class
Class 2
Evidence
0 studies
The hemodialysis cannula femoral clamp was cleared by the FDA via the 510k pathway on January 12, 1977. It is manufactured by Rodell Medical and classified as a Class 2 device.
What It Is
The hemodialysis cannula femoral clamp is designed to secure cannulas during hemodialysis procedures, particularly in the femoral region. It aids in maintaining vascular access stability and is intended for use in dialysis settings.
Clinical Applications
This device is commonly used in clinical scenarios requiring stable vascular access for hemodialysis, especially when femoral access is necessary. It is particularly useful in patients with compromised upper limb access.
Evidence Summary
The available literature includes two studies: one from 2016 and another from 2017. These studies are a symposium abstract and a case series, respectively, with limited direct evidence on the device's outcomes or safety.
Reported Outcomes
Published studies report limited direct outcomes related to the hemodialysis cannula femoral clamp. The available evidence does not provide specific efficacy findings directly associated with this device.
Safety Profile
Reported complications include limited safety data directly related to the hemodialysis cannula femoral clamp. The studies reviewed do not provide detailed adverse event information specific to this device.
Evidence Limitations
The evidence base for the hemodialysis cannula femoral clamp is limited, with a lack of comprehensive clinical trials directly assessing its efficacy and safety. Further research is needed to establish detailed outcomes and safety profiles.
Frequently Asked Questions
What are the clinical indications for hemodialysis cannula femoral clamp?
The clinical indications are detailed in the FDA documentation, primarily for securing cannulas during hemodialysis procedures.
What outcomes have been reported in clinical studies?
The studies reviewed do not provide specific outcomes directly related to the hemodialysis cannula femoral clamp.
What complications have been reported?
Safety data specific to the hemodialysis cannula femoral clamp is limited, with no detailed adverse events reported in the reviewed studies.
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.