# K861310: Stockert-Shiley Aortic Root Cannulae

- Pathway: 510(k) (Traditional)
- Applicant: Shiley, Inc.
- Decided: May 30, 1986 after 52 days
- Product code: DWF (Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass)
- Device class: 2
- Regulation: 21 CFR 870.4210
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
2 later devices descend from it; 1 cites it directly.
0 of 3 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
- K200612: R501 aortic root cannula without vent line, R502 aortic root cannula with vent line (2020), 1 descendant of its own
- K240193: R501 - R502 aortic root cannulae with and without vent line (R501-15: R501-20: R501-26. R502-15; R502-20: R502-26) (2024), 0 descendants of its own

Source page: https://510kreport.com/device/K861310
Methodology: https://510kreport.com/methodology