(167 days)
The I.V. Extension Set is an accessory device used for infusion of medication intravenously into the patient.
Not Found
The provided text is a 510(k) clearance letter from the FDA for an "I.V. Extension Set." This document does not contain any information regarding acceptance criteria, device performance details, or any study results.
The letter confirms that the device is substantially equivalent to legally marketed predicate devices and can be marketed subject to general controls. It details regulatory requirements but does not include any technical or performance specifications or clinical study summaries.
Therefore, I cannot provide the requested information based on the given text.
§ 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.