# K971966: Coronary Vein Graft Tag Marker

- Pathway: 510(k) (Traditional)
- Applicant: Med-Edge, Inc.
- Decided: Jan 26, 1998 after 243 days
- Product code: KPK (Marker, Ostia, Aorto-Saphenous Vein)
- Device class: 2
- Regulation: 21 CFR 878.4650
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
2 later devices descend from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K050384: Kapp Bari-Ring, Model KS-BR-2005 (2006), 1 descendant of its own
- K072216: Kapp Bari-Ring Endoscopic Marker, Model K-9536 (2007), 0 descendants of its own

## Indications for 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 thie 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.

Source page: https://510kreport.com/device/K971966
Methodology: https://510kreport.com/methodology