# K031827: Ultraflex Venous Cannula, Model 970XX and CB970XX

- Pathway: 510(k) (Special)
- Applicant: Medtronic Perfusion Systems
- Decided: Jul 2, 2003 after 19 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 K845045 (1985). 3 ancestors in all.
15 later devices descend from it; 2 cite it directly.
2 of 19 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K845045: Venous Return  Catheter SS-1, Dlp, Inc. (1985) Summary page 1.
- K924642: Medtronic Bio-Medicus Femoral Cannula/Introducer, Medtronic Bio-Medicus, Inc. (1993) Summary page 1.
- K891687: Extracorporeal Circuit with Bio-Active Surface, Medtronic Blood Systems, Inc. (1989)

## Most influential descendants
- K052081: Remote Access Perfusion (Rap) Femoral Venous Cannula (2005), 8 descendants of its own
- K060101: Estech Aortic Easy Flow Cannula (2006), 6 descendants of its own
- K111972: Affinity CP Centrifugal Pump, Resting Heart Sys.,Myotherm Cardioplegia Deliv.,Affinity Hollow Fiber Oxygenator,Aaf (2011), 5 descendants of its own
- K120988: DLP Single Stage Venous Cannula, DLP Right Angle Single Stage Venous Cannula, DLP Single Stage Venous Cannula with Right (2012), 4 descendants of its own
- K083111: Impella 5.0 Catheter Family (2009), 3 descendants of its own

## Indications for use
These cannulae are intended for use in venous drainage via the right atrium and inferior vena cava simultaneously during cardiopulmonary bypass surgery.

Source page: https://510kreport.com/device/K031827
Methodology: https://510kreport.com/methodology