Search Results

GraviTech™ is a single use, disposable gravity-driven flow regulator used in conjunction with I.V. administration sets and extension sets for controlling the flow rate of I.V. solutions into the human body.

GraviTech™ Primary Sets are for use in controlling the infusion rate of I.V. fluids from the solution bag to a patient catheter, which is inserted into a human vein.

GraviTech™ Extension Sets are intended for use in conjunction with commonly used I.V. primary sets for controlling the infusion rate of I.V. fluids into the human body.

GraviTech™ is a single use, disposable gravity-driven flow regulator used in conjunction with I.V. administration sets and extension sets for controlling the flow rate of I.V. solutions into the human body.

The provided text is a 510(k) premarket notification letter from the FDA to IV Medical, Incorporated regarding their GraviTech™ Flow Controller Primary Set/GraviTech™ Flow Controller Extension Set. This document does not contain information about acceptance criteria or a study proving the device meets those criteria.

The 510(k) clearance process primarily establishes substantial equivalence to a legally marketed predicate device, rather than requiring the submission of detailed performance studies against specific acceptance criteria in the same way a PMA (Premarket Approval) would.

Therefore, I cannot provide the requested information based on the given text.

Ask a specific question about this device