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510(k) Data Aggregation
(177 days)
HEALTH LINE INTERNATIONAL CORPORATION'S PRIMARY IV SOLUTION ADMINISTRATION SET WITH CHECK VALVE
An intravascular administration set is a device used to administer fluids from a container to a patient's vascular system through a needle or catheter inserted into a vein. The device may include the needle or catheter, tubing, a flow requlator, a drip chamber, an infusion line filter, an I.V. set stopcock, fluid delivery tubing, connectors between parts of the set, a side tube with a cap to serve as an injection site, and a hollow spike to penetrate and connect the tubing to an I.V. bag or other infusion fluid container.
An intravascular administration set is a device used to administer fluids from a container to a patient's vascular system through a needle or catheter inserted into a vein. The device may include the needle or catheter, tubing, a flow requlator, a drip chamber, an infusion line filter, an I.V. set stopcock, fluid delivery tubing, connectors between parts of the set, a side tube with a cap to serve as an injection site, and a hollow spike to penetrate and connect the tubing to an I.V. bag or other infusion fluid container.
The provided documents are a 510(k) clearance letter and an "Indications for Use" statement for the Health Line International Corporation's IV Solution Administration Set with Check Valve. They do not contain information about acceptance criteria or a study proving that a device meets such criteria.
The 510(k) process is for demonstrating substantial equivalence to a predicate device, not for proving performance against specific acceptance criteria through a study as would be detailed for an AI/ML medical device.
Therefore, I cannot extract the requested information from the provided text.
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