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K Number
K971966
Device Name
CORONARY VEIN GRAFT TAG MARKER
Manufacturer
MED-EDGE, INC.
Date Cleared
1998-01-26

(243 days)

Product Code
KPK
Regulation Number
878.4650
Type
Traditional
Panel
CV
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

A radiopaque marker used to identify the coronary vein graft which is commonly used to revascularize the blood supply to the heart. The marker is attached to the distal and / or proximal anastomosis sites of the graft by the surgeon during the CABG procedure. The marker can subsequently be used by the cardiologist during cardiac catheterization as a landmark to easily identify the anastomosis site of the vein graft utilizing fluoroscopy.

Device Description

Not Found

AI/ML Overview

I am sorry, but the provided text is a letter from the FDA regarding a 510(k) premarket notification for a medical device. It does not contain any information about acceptance criteria, device performance studies, sample sizes, or ground truth establishment.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based on the provided text.

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