# K060101: Estech Aortic Easy Flow Cannula

- Pathway: 510(k) (Traditional)
- Applicant: Endoscopic Technologies, Inc.
- Decided: May 10, 2006 after 118 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: 3 generations back to K845045 (1985). 7 ancestors in all.
6 later devices descend from it; 3 cite it directly.
2 of 14 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K934127: Sarns Low Jetting Aortic Arch Cannula, 3M Health Care, Sarns (1994) Summary page 1.
- K052081: Remote Access Perfusion (Rap) Femoral Venous Cannula, Estech, Inc. (2005) Summary page 1.

## Most influential descendants
- K083111: Impella 5.0 Catheter Family (2009), 3 descendants of its own
- K102726: Cardiohelp System (2011), 2 descendants of its own
- K091542: Estech Easyflow Cannula with Guidewire (2009), 1 descendant of its own
- K250610: Easyflow (103-200; 103-300); Easyflow Duo (103-210; 103-310) (2025), 0 descendants of its own
- K133598: Cardiohelp System (2014), 0 descendants of its own

## Indications for use
The ESTECH Aortic Easy Flow Cannula is intended for use in the perfusion of the aorta during cardiovascular surgery procedures requiring extracorporeal cardiopulmonary bypass (CPB) up to 6 hours.

Source page: https://510kreport.com/device/K060101
Methodology: https://510kreport.com/methodology