(90 days)
To sample blood or administer drug solutions, blood products, and other fluids intravenously. These catheters may be used for any patient population with consideration given to patient size, appropriateness for the solution being infused, and duration of therapy.
The subject catheter is a short term, single use, intravascular catheter of various French sizes and lengths which is designed to provide access to large veins such as the baslic or cephalic veins. It is inserted into the vascular system through a spittable introducer catheter.
The provided text describes a 510(k) premarket notification for an intravascular catheter, specifically the Becton Dickinson FIRST MIDCATH™ Catheter with Dual Lumens. This document focuses on establishing substantial equivalence to a predicate device and does not contain information about acceptance criteria for device performance, a study proving the device meets specific criteria, or any details related to AI/ML device performance or validation.
Therefore, I cannot fulfill the request as the necessary information is absent from the provided text. The document is concerned with regulatory approval based on equivalence to an existing device, not a performance study against specific acceptance criteria.
§ 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).