# K033416: Select 3D Arterial Cannula with Carmeda Bioactive Surface and Select Cap Arterial Cannula with Carmeda Bioactive Surface

- Pathway: 510(k) (Special)
- Applicant: Medtronic Perfusion Systems
- Decided: Nov 5, 2003 after 9 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: 2 generations back to K840002 (1984). 5 ancestors in all.
11 later devices descend from it; 4 cite it directly.
0 of 17 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 1.
- K000776: Medtronic DLP Arterial Cannulae with 3D Tip, Medtronic Cardiac Surgical Products (2001) Summary page 1.
- K013013: Medtronic DLP Arterial Cannula with 3D Tip - 22 FR., Medtronic Cardiac Surgical Products (2001) Summary page 1.
- K010737: Select Cap Arterial Cannula with Pressure Monitoring Line, Model 78818,78820,78822,78824,78918,78920,78922,78924, Medtronic Cardiac Surgical Products (2001)
- K891687: Extracorporeal Circuit with Bio-Active Surface, Medtronic Blood Systems, Inc. (1989) Summary page 1.

## Most influential descendants
- 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
- 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

## Recalls of this device
- Jan 30, 2014 · Class II · Z-0999-2014: 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.
- May 9, 2008 · Not classified · Z-1926-2008: Medtronic is recalling selected Carmeda-coated cardiopulmonary bypass (CPB) products (e.g., oxygenators, reservoirs, pumps, cannulae and tubing packs) that were manufactured with contaminated heparin.

## 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/K033416
Methodology: https://510kreport.com/methodology