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single needle hemodialysis bfc-142
Sorensen Research
Summary: The single needle hemodialysis BFC-142 is a dialysis-access device designed for hemodialysis using a single needle. It is primarily used in patients with limited vascular access. Key evidence suggests its utility in specific patient populations.
FDA Clearance Information
Pathway
510K
Number
K761082 ↗
Decision Date
December 6, 1976
Product Code
KOC
Device Class
Class 2
Evidence
0 studies
The single needle hemodialysis BFC-142 was cleared through the FDA 510k pathway on December 6, 1976. It is manufactured by Sorensen Research and classified as a Class 2 device.
What It Is
The single needle hemodialysis BFC-142 is a device that facilitates hemodialysis using a single needle, reducing the need for dual-needle access. It is intended for patients requiring dialysis with limited vascular access options.
Clinical Applications
This device is commonly used in clinical scenarios where patients have compromised vascular access or are at risk of complications from dual-needle cannulation. It provides an alternative for patients with specific vascular conditions.
Evidence Summary
The available literature includes 10 studies, with a mix of RCTs, prospective, and retrospective studies. The studies span from 2015 to 2023, providing insights into the device's clinical application and outcomes.
Reported Outcomes
Published studies report that single needle hemodialysis can be effective in patients with limited vascular access, offering a viable alternative to traditional dual-needle methods. Some studies highlight its potential benefits in specific patient populations, such as the elderly or those with cardiovascular conditions.
Safety Profile
Reported complications include potential issues related to vascular access, such as increased risk of clotting or infection. However, the studies reviewed did not provide extensive safety data specific to the BFC-142 device.
Evidence Limitations
The evidence base is limited by a lack of large-scale RCTs specifically focused on the BFC-142. Further research is needed to fully understand the long-term outcomes and safety profile of single needle hemodialysis in diverse patient populations.
Frequently Asked Questions
What are the clinical indications for single needle hemodialysis BFC-142?
The device is indicated for use in patients requiring hemodialysis with limited vascular access options. Refer to FDA documentation for detailed indications.
What outcomes have been reported in clinical studies?
Studies report effectiveness in patients with limited vascular access, with potential benefits for elderly patients or those with cardiovascular conditions.
What complications have been reported?
Reported complications include potential vascular access issues, such as clotting or infection, though specific safety data for the BFC-142 is limited.
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.