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510(k) Data Aggregation
(241 days)
EXTRESAFE PHLEBOTOMY
The ExtreSafe™ Phlebotomy device is intended to be used in phlebotomy procedures using vacuum blood collection tubes. A powered needle retraction feature provided a shield for the necure f 11 following use.
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The provided document is a 510(k) premarket notification letter from the FDA regarding the Extresafe™ Phlebotomy device. This document does not describe any acceptance criteria or a study proving the device meets acceptance criteria. It primarily states that the device is substantially equivalent to legally marketed predicate devices and can proceed to market.
Therefore, I cannot provide the requested information from the given document as it is not present.
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