K Number
K162377
Manufacturer
Date Cleared
2016-09-22

(29 days)

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

The PowerGlide Pro™ Midline Catheter is inserted into a patient's vascular system for short-term use (

Device Description

The PowerGlide Pro™ Midline Catheter is a sterile, single use device designed to provide access to the patient's vascular system. The device is intended for short term use (

AI/ML Overview

The provided document describes the PowerGlide Pro™ Midline Catheter, which is an intravascular catheter intended for short-term use (

§ 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).