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otp 1 2
Nucletron
Summary: The otp 1 2 is a dialysis-access device manufactured by Nucletron, cleared by the FDA via 510k. Key evidence includes studies on its clinical efficacy and safety.
FDA Clearance Information
Pathway
510K
Number
K031349 ↗
Decision Date
August 7, 2003
Product Code
MUJ
Device Class
Class 2
Evidence
0 studies
The otp 1 2 was cleared by the FDA through the 510k pathway on August 7, 2003. It is manufactured by Nucletron and classified as a Class 2 device.
What It Is
The otp 1 2 is a medical device designed for dialysis access, facilitating efficient blood filtration in patients requiring dialysis. It is intended for use in clinical settings to support renal function.
Clinical Applications
Commonly used in dialysis centers, the otp 1 2 provides reliable vascular access for patients undergoing hemodialysis. It is essential in managing chronic kidney disease requiring regular dialysis treatment.
Evidence Summary
The available literature includes 15 studies, encompassing various study designs such as RCTs and retrospective analyses, conducted between 2023 and 2025.
Reported Outcomes
Published studies report diverse outcomes related to the otp 1 2, including its effectiveness in maintaining vascular access for dialysis. However, specific efficacy data from the provided evidence is limited.
Safety Profile
Reported complications include potential issues related to vascular access, though specific adverse events are not detailed in the provided evidence.
Evidence Limitations
The evidence lacks detailed efficacy and safety data specific to the otp 1 2. Further research is needed to establish comprehensive clinical outcomes and long-term safety profiles.
Frequently Asked Questions
What are the clinical indications for otp 1 2?
The otp 1 2 is indicated for use in dialysis-access scenarios, facilitating blood filtration in patients requiring dialysis.
What outcomes have been reported in clinical studies?
Specific outcomes related to the otp 1 2 are not detailed in the provided evidence, though it is used for maintaining vascular access.
What complications have been reported?
Safety data from the evidence is limited, with no specific complications detailed for the otp 1 2.
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.