LogoFDA 510(k) Search
K Number
K120008
Device Name
MEDLINE HIGH PRESSURE INJECTION TUBING
Manufacturer
MEDLINE, INDUSTRIES, INC.
Date Cleared
2012-08-17

(227 days)

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

The Medline High Pressure Tubing is indicated for use during coronary angiography procedures as a connecting line for the injection of radiopaque dye or saline.

Device Description

Not Found

AI/ML Overview

I am sorry, but the provided text does not contain any information regarding the acceptance criteria, study details, or device performance as requested. The document is an FDA 510(k) clearance letter for a medical device called "Medline High Pressure Tubing," indicating its substantial equivalence to a predicate device and specifying its intended use. It does not include any performance data or study design details.

§ 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).