# K052081: Remote Access Perfusion (Rap) Femoral Venous Cannula

- Pathway: 510(k) (Traditional)
- Applicant: Estech, Inc.
- Decided: Dec 16, 2005 after 136 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: 2 generations back to K845045 (1985). 5 ancestors in all.
8 later devices descend from it; 2 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)
- K031827: Ultraflex Venous Cannula, Model 970XX and CB970XX, Medtronic Perfusion Systems (2003) Summary page 1.
- K891576: Fem-Flex Femoral Access Cannulation Set, Research Medical, Inc. (1989) Summary page 1.

## Most influential descendants
- K060101: Estech Aortic Easy Flow Cannula (2006), 6 descendants of its own
- 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
- K250283: RAP Femoral Venous Cannulae (2025), 0 descendants of its own

## Recalls of this device
- Sep 28, 2017 · Class II · Z-0076-2018: A specific lot of the FlexFlowTM Venous Cannula, 200-200, is being recalled because it is sharper or pointier than expected.

## Indications for use
The ESTECH Remote Access Perfusion Femoral Venous Cannula is intended for use as a venous drainage cannula during cardiopulmonary bypass up to 6 hours.

Source page: https://510kreport.com/device/K052081
Methodology: https://510kreport.com/methodology