(140 days)
The CODAN IV Administration Set is indicated to facilitate the infusion of IV fluids from a plastic bag or solution container into the patient.
Not Found
This document is a 510(k) premarket notification letter from the FDA regarding an I.V. Administration Set. It does not contain any information about acceptance criteria or a study proving the device meets acceptance criteria.
Therefore, I cannot provide the requested information. The document focuses on regulatory approval and substantial equivalence to legally marketed predicate devices, not on the performance metrics of the device itself.
§ 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.