# K091542: Estech Easyflow Cannula with Guidewire

- Pathway: 510(k) (Traditional)
- Applicant: Endoscopic Technologies, Inc. D/B/A Estech
- Decided: Oct 20, 2009 after 147 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: 4 generations back to K845045 (1985). 14 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 16 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K060101: Estech Aortic Easy Flow Cannula, Endoscopic Technologies, Inc. (2006) Summary page 1.
- K000274: Eopa Elongated One-Piece Arterial Cannula with Guidewire, Medtronic Cardiac Surgical Products (2000) Summary page 1.
- K974259: Venous Flex II Peripheral and Intra-Operative Access Venous Return Cannulae, Edwards Lifesciences Research Medical (1998) Summary page 1.
- K070749: Estech Percutaneous Insertion Dilator Kit, Coombs Medical Device Consulting (2007) Summary page 2.

## Most influential descendants
- K250610: Easyflow (103-200; 103-300); Easyflow Duo (103-210; 103-310) (2025), 0 descendants of its own

## Indications for use
The ESTECH EasyFlow Cannula with Guidewire is intended for use with cardiopulmonary bypass as an arterial return or venous drainage cannula for up to 6 hours.

Source page: https://510kreport.com/device/K091542
Methodology: https://510kreport.com/methodology