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K Number
K160660
Device Name
Medline Waste Station
Manufacturer
Medline Industries, Inc.
Date Cleared
2017-01-19

(317 days)

Product Code
DQO
Regulation Number
870.1200
Type
Traditional
Panel
Cardiovascular
Reference & Predicate Devices
N/A
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

The Medline Waste Station is intended for syringe fluid administration, and waste collection. The Waste Station is for use during catheterization procedures and fluid delivery and for the temporary storage of waste fluids from invasive radiology, cardiology, and CT lab procedures.

Device Description

Not Found

AI/ML Overview

This document is a 510(k) clearance letter from the FDA for a medical device called the "Medline Waste Station." It does not contain information about acceptance criteria, device performance studies, or details regarding AI/algorithm performance. The letter is primarily about regulatory clearance based on substantial equivalence to a predicate device.

Therefore, I cannot extract the requested information from this document.

§ 870.1200 Diagnostic intravascular catheter.

(a)
Identification. An intravascular diagnostic catheter is a device used to record intracardiac pressures, to sample blood, and to introduce substances into the heart and vessels. Included in this generic device are right-heart catheters, left-heart catheters, and angiographic catheters, among others.(b)
Classification. Class II (performance standards).