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510(k) Data Aggregation
(72 days)
ACT MEDICAL, INC.
The FlexNeedle ® Plus is intended for use in the short term or intermittent transcutaneous cannulation of implanted venous access ports and is designed with the purpose of reducing accidental needlesticks.
The FlexNeedle Plus is comprised of a flexible catheter, a body with elastomeric septum and side port; sidearm tubing with a luer infusion fitting, cap and pinch clamp; and an insertion stylet with a safety housing for capturing the sharp upon removal.
The provided text is a 510(k) summary for the FlexNeedle® Plus Intravascular Administration Set. It describes the device, its intended use, and its substantial equivalence to predicate devices. However, this document does not contain any information regarding acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert involvement as requested in your prompt.
Therefore, I cannot provide the requested table and details based on the given input. The 510(k) summary focuses on regulatory approval based on equivalence rather than detailed performance study results against specific criteria.
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(153 days)
ACT MEDICAL, INC.
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