(74 days)
For simplifying insertion of a guide-wire and/or catheter through various ports(such as a Touhy-Borst) used in intravascular administration sets.
Blunt Needle
This document is a 510(k) clearance letter from the FDA for a "Manan Blunt Needle." It's a regulatory document indicating substantial equivalence to a predicate device, and it does not contain information about acceptance criteria or a study proving device performance as requested.
Therefore, I cannot provide the requested information based on the given input.
§ 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.