(123 days)
Extension sets are for administering fluids from container to a patient's vascular system through a vascular access device.
Needleless valve allows the user to add medication into the without the use of a needle.
Power Injection Rating and Flowrate (400 psi and 10 mL/sec).
Not Found
I am sorry, but the provided text does not contain information about acceptance criteria, device performance, or any study details that would enable me to answer your request. The document is an FDA 510(k) clearance letter for a medical device called "NeutrArt," an intravascular administration set. It discusses regulatory matters, indications for use, and administrative information, but it does not include clinical study data or performance metrics.
§ 880.5440 Intravascular administration set.
(a)
Identification. 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 regulator, 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.(b)
Classification. Class II (special controls). The special control for pharmacy compounding systems within this classification is the FDA guidance document entitled “Class II Special Controls Guidance Document: Pharmacy Compounding Systems; Final Guidance for Industry and FDA Reviewers.” Pharmacy compounding systems classified within the intravascular administration set are exempt from the premarket notification procedures in subpart E of this part and subject to the limitations in § 880.9.