# K831591: Aortic Root Cannula W/Integral Press

- Pathway: 510(k) (Traditional)
- Applicant: Dlp, Inc.
- Decided: Jun 30, 1983 after 44 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
No predicates in its family tree.
4 later devices descend from it; 3 cite it directly.
1 of 5 devices in its family (counting itself) has 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
- K040173: Pediatric Aortic Root Cannula (2004), 1 descendant of its own
- K182586: DLP Aortic Root Cannula, DLP Aortic Root Cannula with Vent Line, DLP Pressure Monitoring Extension Line Adapter, DLP Cardioplegia Adapter with Pressure Port (2018), 0 descendants of its own
- K100274: Miar (Minimally Invasive Aortic Root) Cannula with Flow-Guard, Models 11012L and 11014L (2010), 0 descendants of its own
- K012143: 24 FR. Left Heart Vent Catheter with Pressure Monitoring Line, Model 12524 (2001), 0 descendants of its own

## Recalls of this device
- Jun 22, 2017 · Class II · Z-2767-2017: Identification of small pinholes in a single packaging configuration of sterile pouches. A total of seven different products were affected.
- Jun 22, 2017 · Class II · Z-2766-2017: Identification of small pinholes in a single packaging configuration of sterile pouches. A total of seven different products were affected.

Source page: https://510kreport.com/device/K831591
Methodology: https://510kreport.com/methodology