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510(k) Data Aggregation
(114 days)
MEDRAD AVANTA FLUID MANAGEMENT INJECTION SYSTEM
The MEDRAD Avanta™ Fluid Management Injection System is indicated for the controlled administration of intravascular radio-opaque contrast media and common flushing solutions to humans during angiographic procedures.
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This document is a 510(k) premarket notification approval letter from the FDA to Medrad, Inc. for their Avanta Fluid Management Injection System. It does not contain information about acceptance criteria or a study proving that the device meets those criteria. Such information would typically be found in the 510(k) submission itself or in a summary of safety and effectiveness, neither of which is provided here.
Therefore, I cannot fulfill the request for information regarding acceptance criteria, device performance, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth details. The provided text only states that the device is substantially equivalent to legally marketed predicate devices for the indications for use.
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