(147 days)
Venous/arterial umbilical access in infants for infusion through one lumen and monitoring/blood sampling through the second lumen. May also be used for the infusion of incompatable solutions, through separate lumens.
Double Lumen Umbilical Catheter
This document is a 510(k) clearance letter from the FDA for a medical device called the "Vygon Double Lumen Umbilical Catheter" (K981630). It is a regulatory approval document and not a scientific study report.
Therefore, the information requested regarding acceptance criteria, study details, sample sizes, ground truth establishment, expert qualifications, and MRMC studies cannot be extracted from this document. This letter confirms that the device is substantially equivalent to legally marketed predicate devices, but it does not provide the specific performance data or the study design used to make that determination.
§ 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).