# K013013: Medtronic DLP Arterial Cannula with 3D Tip - 22 FR.

- Pathway: 510(k) (Traditional)
- Applicant: Medtronic Cardiac Surgical Products
- Decided: Dec 4, 2001 after 88 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: 1 generation back to K840002 (1984). 2 ancestors in all.
12 later devices descend from it; 2 cite it directly.
0 of 15 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K840002: Arterial Cannula Curved Beveled Tip, Dlp, Inc. (1984) Summary page 2.
- K000776: Medtronic DLP Arterial Cannulae with 3D Tip, Medtronic Cardiac Surgical Products (2001) Summary page 2.

## Most influential descendants
- K033416: Select 3D Arterial Cannula with Carmeda Bioactive Surface and Select Cap Arterial Cannula with Carmeda Bioactive Surface (2003), 11 descendants of its own
- K043179: Select 3D Arterial Cannula (2005), 10 descendants of its own
- K061254: Eopa 3D Arterial Cannula, Models 78220,78222,78320,783222 (2006), 8 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

## Recalls of this device
- Jan 30, 2014 · Class II · Z-0996-2014: Medtronic is recalling all models of its Select 3D and Select CAP Arterial Cannula product families due to reports of the cannula body splitting near the suture collar.

## Indications for use
These cannulae are intended for use in perfusion of the ascending aorta during short-term (6 hours or less) cardiopulmonary bypass.

Source page: https://510kreport.com/device/K013013
Methodology: https://510kreport.com/methodology