# K120612: Medtronic Clear Intravacular Arteriotomy Shunt

- Pathway: 510(k) (Special)
- Applicant: Medtronic, Inc.
- Decided: May 25, 2012 after 86 days
- Product code: DWF (Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass)
- Device class: 2
- Regulation: 21 CFR 870.4210
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K993677 (2000). 1 ancestor in all.
1 later device descends 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)
- K993677: Medtronic Clearview Intravascular Arteriotomy Shunt, Medtronic Vascular (2000) Summary page 1.

## Most influential descendants
- K253998: Clearview Intracoronary Shunts (2026), 0 descendants of its own

## Recalls of this device
- Mar 19, 2024 · Class II · Z-1803-2024: Potential for unsealed sterile packing.

## Indications for use
These shunts (Clearview® Intracoronary Shunts) are intended for use to shunt blood by the arteriotomy anastomosis site while the surgeon is making the anastomosis.

Source page: https://510kreport.com/device/K120612
Methodology: https://510kreport.com/methodology