# K052642: Suturing Washer

- Pathway: 510(k) (Traditional)
- Applicant: First Call, Inc.
- Decided: Jan 17, 2006 after 113 days
- Product code: MAB (Marker, Cardiopulmonary Bypass (Vein Marker))
- Device class: 2
- Regulation: 21 CFR 870.3450
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K864101 (1986). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K864101: Cook (R) Vein Graft Ring Markers, Cook, Inc. (1986) Summary page 1.

## Indications for use
This single use device is for radiological identification of the aortic anastomosis in coronary artery bypass surgery

Source page: https://510kreport.com/device/K052642
Methodology: https://510kreport.com/methodology