# K022272: Malleable Single Stage Venous Cannula, Models 68112-68140 (15 Total Codes)

- Pathway: 510(k) (Traditional)
- Applicant: Medtronic Cardiac Surgical Products
- Decided: Jan 8, 2003 after 177 days
- Product code: DWF (Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass)
- Device class: 2
- Regulation: 21 CFR 870.4210
- Recalls of this device: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K845045 (1985). 1 ancestor in all.
7 later devices descend from it; 2 cite it directly.
0 of 9 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.

## Most influential descendants
- K033264: Malleable Single Stage Venous Cannula with Carmeda Bioactive Surface, Model CB681XX Series (2003), 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
- K140165: MC2 Two-Stage Venous Cannula, Oval MC2 Two-Stage Venous Cannula, Thin Wall Two-Stage Venous Cannula, MC2X Three-Stage VE (2014), 2 descendants of its own
- K251258: MC2™ Two-Stage Venous Cannula; MC2X™ Three-Stage Venous Cannula (2025), 1 descendant of its own

## Recalls of this device
- Mar 19, 2024 · Class II · Z-1805-2024: Potential for unsealed sterile packing.
- Dec 14, 2011 · Not classified · Z-0812-2012: Instructions for Use for the DLP Single Stage Venous Cannulae are in the process of being updated. The current precaution statement referencing ventricular assist procedures will be identified as a co
- Dec 14, 2011 · Not classified · Z-0810-2012: Instructions for Use for the DLP Single Stage Venous Cannulae are in the process of being updated. The current precaution statement referencing ventricular assist procedures will be identified as a co

## Indications for use
These cannulae are intended for collection of venous blood from the right side of the heart via the superior and inferior vena cava during cardiopulmonary bypass surgery.

Source page: https://510kreport.com/device/K022272
Methodology: https://510kreport.com/methodology