K Number
K982558
Manufacturer
Date Cleared
2000-03-08

(595 days)

Product Code
Regulation Number
880.5200
Panel
HO
Reference & Predicate Devices
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

Maintain patency of vascular devices

Device Description

Sterile Plastic Luer Lock Syringes of various sizes Filled with sterile saline

AI/ML Overview

I am sorry, but the provided text does not contain information about the acceptance criteria or a study proving that a device meets those criteria. The document is a 510(k) summary for Preefil® Normal Saline Flush Syringes, focusing on its substantial equivalence to a predicate device and its intended use. It does not detail specific performance metrics, studies, or evaluation methodologies beyond the comparison with another flush device. Therefore, I cannot generate the requested table and information.

§ 880.5200 Intravascular catheter.

(a)
Identification. An intravascular catheter is a device that consists of a slender tube and any necessary connecting fittings and that is inserted into the patient's vascular system for short term use (less than 30 days) to sample blood, monitor blood pressure, or administer fluids intravenously. The device may be constructed of metal, rubber, plastic, or a combination of these materials.(b)
Classification. Class II (performance standards).