# K032632: Remote Access Perfusion Cannula Left Axillary 21 French

- Pathway: 510(k) (Abbreviated)
- Applicant: Estech, Inc.
- Decided: Oct 22, 2003 after 57 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: 1 generation back to K990573 (1999). 2 ancestors in all.
4 later devices descend from it; 1 cites it directly.
2 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K990573: Estech Arterial Remote Access Perfusion Cannula, Estech, Inc. (1999) Summary page 1.
- K002578: Axillary Access Arterial Cannula, Edwards Lifesciences, LLC (2002)

## Most influential descendants
- K083111: Impella 5.0 Catheter Family (2009), 3 descendants of its own
- K102726: Cardiohelp System (2011), 2 descendants of its own
- K133598: Cardiohelp System (2014), 0 descendants of its own
- K133265: Quadrox-IR Adult and Small Adult (2013), 0 descendants of its own

## Indications for use
The ESTECH Remote Access Perfusion Cannula Left Axillary 21 French is intended for use in arterial perfusion of the aorta, via axillary artery, in cardiovascular surgery procedures requiring extracorporeal cardiopulmonary bypass (CPB). This device is indicated for short term cardiopulmonary bypass (< 6 hours). The device may also be used to occlude the ascending aorta, deliver cardioplegia solution and vent the aortic root.

Source page: https://510kreport.com/device/K032632
Methodology: https://510kreport.com/methodology