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K Number
K042984
Device Name
INTERGARD WOVEN CONNECTOR GRAFT, MODEL IGW0030-10C
Manufacturer
INTERVASCULAR
Date Cleared
2005-02-18

(112 days)

Product Code
DWF
Regulation Number
870.4210
Type
Traditional
Panel
CV
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

The InterGard Woven Connector Graft is intended for use in arterial perfusion of the aorta, via femoral or axillary artery, for cardiopulmonary bypass when extracorporeal circulation is required for periods up to six (6.0) hours.

Device Description

InterGard Woven Connector Graft

AI/ML Overview

I am sorry, but the provided text does not contain the information required to answer your request. The document appears to be an FDA 510(k) clearance letter for a medical device (InterGard Woven Connector Graft) and details its indications for use. However, it does not include any specifics about acceptance criteria, study methodologies, sample sizes, ground truth establishment, or comparative effectiveness studies for the device.

§ 870.4210 Cardiopulmonary bypass vascular catheter, cannula, or tubing.

(a)
Identification. A cardiopulmonary bypass vascular catheter, cannula, or tubing is a device used in cardiopulmonary surgery to cannulate the vessels, perfuse the coronary arteries, and to interconnect the catheters and cannulas with an oxygenator. The device includes accessory bypass equipment.(b)
Classification. Class II (performance standards).