# K840002: Arterial Cannula Curved Beveled Tip

- Pathway: 510(k) (Traditional)
- Applicant: Dlp, Inc.
- Decided: Feb 13, 1984 after 41 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
No predicates in its family tree.
13 later devices descend from it; 3 cite it directly.
0 of 14 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K013013: Medtronic DLP Arterial Cannula with 3D Tip - 22 FR. (2001), 12 descendants of its own
- 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

## Recalls of this device
- Dec 12, 2024 · Class II · Z-0986-2025: Incorrect labeling for seven manufactured lots of certain models of Arterial Cannulae.
- Mar 19, 2024 · Class II · Z-1793-2024: Potential for unsealed sterile packing.
- May 9, 2008 · Not classified · Z-1927-2008: 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.

Source page: https://510kreport.com/device/K840002
Methodology: https://510kreport.com/methodology