(274 days)
Indicated to permit short-term (
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The provided text is a 510(k) premarket notification letter from the FDA to Ameco Medical Industries for their "Amecath CVC" and "Amecath Pressure CVC" short-term single and multi-lumen catheterization kits.
This document is a regulatory approval letter and an "Indications for Use" statement. It does not contain any information about acceptance criteria for a device's performance, nor does it describe any study (clinical or otherwise) that proves the device meets such criteria.
Therefore, I cannot provide the requested information from this document. The document primarily focuses on regulatory approval, classification, and general responsibilities under the Federal Food, Drug, and Cosmetic Act.
§ 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).