FOOTPRINT MEDICAL UMBILICAL CATHETER, DUAL LUMEN

• K Number: K091213
• Device Name: FOOTPRINT MEDICAL UMBILICAL CATHETER, DUAL LUMEN
• Manufacturer: FOOTPRINT MEDICAL
• Date Cleared: 2009-09-25 ( 151 days)
• Product Code: FOS
• Regulation Number: 880.5200
• Type: Traditional
• Panel: HO
• Reference & Predicate Devices: N/A

Intended Use

THIS PRODUCT IS INTENDED FOR USE IN NEONATAL AND PEDIATRIC PATIENTS TO SAMPLE BLOOD, MONITOR BLOOD PRESSURE OR ADMINISTER FLUIDS INTRAVENOUSLY.

Device Description

FOOTPRINT MEDICAL SILICONE UMBILICAL CATHETER, DUAL LUMEN.

AI/ML Overview

This document is a 510(k) premarket notification approval letter from the FDA for a Silicone Umbilical Catheter, Dual Lumen. It does not contain any information about acceptance criteria or a study proving that a device meets acceptance criteria.

The letter only states that the device is substantially equivalent to legally marketed predicate devices and is subject to general controls provisions of the Act.

Therefore, I cannot provide the requested information based on the provided text.

Regulation Number and Section

§ 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).