V SET

• K Number: K020419
• Device Name: V SET
• Manufacturer: P.T. GREENLEAF
• Date Cleared: 2003-08-29 ( 568 days)
• Product Code: FPA
• Regulation Number: 880.5440
• Type: Traditional
• Panel: General Hospital
• Reference & Predicate Devices: N/A
• Predicate For: N/A

Intended Use

The Y Set is suitable for intravenous infusion of drug solutions and fluids and has been designed to connect multiple infusion lines, functioning in the administration of intravenous fluids from a number of sources into one cannula. The device will be available only by prescription and will carry the following legend: "Caution : Federal Law restricts this device to sale by or on the order of a physician". (21 (FR 801.109(b)(1))

Device Description

Not Found

AI/ML Overview

I am sorry, but the provided text does not contain information about acceptance criteria, device performance, or any studies conducted on the V Set device. The document is a 510(k) clearance letter from the FDA, indicating that the device has been found substantially equivalent to a predicate device, allowing it to be marketed. It defines the device, its intended use, and regulatory information, but does not include any performance data or study details.

Therefore, I cannot provide the requested information in the specified format.

Regulation Number and Section

§ 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.