# K253998: Clearview Intracoronary Shunts

- Pathway: 510(k) (Special)
- Applicant: Medtronic, Inc.
- Decided: Jan 20, 2026 after 39 days
- Product code: DWF (Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass)
- Device class: 2
- Regulation: 21 CFR 870.4210
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K993677 (2000). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K120612: Medtronic Clear Intravacular Arteriotomy Shunt, Medtronic, Inc. (2012) Summary page 5.

## Indications for use
The device is indicated for temporary use during the creation of anastomosis for medical conditions requiring beating heart coronary artery bypass procedures.

Source page: https://510kreport.com/device/K253998
Methodology: https://510kreport.com/methodology