# K120988: DLP Single Stage Venous Cannula, DLP Right Angle Single Stage Venous Cannula, DLP Single Stage Venous Cannula with Right

- Pathway: 510(k) (Special)
- Applicant: Medtronic, Inc.
- Decided: Jul 25, 2012 after 114 days
- Product code: DWF (Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass)
- Device class: 2
- Regulation: 21 CFR 870.4210
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K840002 (1984). 76 ancestors in all.
4 later devices descend from it; 2 cite it directly.
1 of 81 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K842375: Venous Cannula W/Bent, Tip Wire, Dlp, Inc. (1984). Our reading of the summary gave K842374, FDA’s number for Novametrix 850 Transcutaneous Oxygen (Novametrix Medical Systems, Inc.). Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “Venous Cannula with Bent Tip Wire”.
- K022272: Malleable Single Stage Venous Cannula, Models 68112-68140 (15 Total Codes), Medtronic Cardiac Surgical Products (2003) Summary page 1.
- K111972: Affinity CP Centrifugal Pump, Resting Heart Sys.,Myotherm Cardioplegia Deliv.,Affinity Hollow Fiber Oxygenator,Aaf, Medtronic, Inc. (2011) Summary page 1.
- K845045: Venous Return  Catheter SS-1, Dlp, Inc. (1985) Summary page 2.

## Most influential descendants
- 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
- K262052: Tri Stage Venous Cannulae (2026), 0 descendants of its own
- K250937: Venous Return Cannulae (2026), 0 descendants of its own

## Recalls of this device
- Jul 9, 2024 · Class II · Z-3128-2024: During manufacturing, DLP Single Stage Venous Cannulae - straight tip (Model 66118) was incorrectly placed into a product labeled as DLP Single Stage Venous Cannulae - right angle metal tip (Model 673
- Feb 19, 2013 · Class II · Z-0908-2013: Potential for uncharacteristically rough metal edges to occur along the inner diameter of the metal tip side ports of the cannula.

## 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 up to six hours of less.

Source page: https://510kreport.com/device/K120988
Methodology: https://510kreport.com/methodology