# K810820: Cardiopulmonary Bypass

- Pathway: 510(k) (Traditional)
- Applicant: Dlp, Inc.
- Decided: Apr 3, 1981 after 10 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.
1 later device descends from it; 1 cites it directly.
0 of 2 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
- K111147: Medline Vessel Cannula (2011), 0 descendants of its own

## Recalls of this device
- Mar 19, 2024 · Class II · Z-1796-2024: Potential for unsealed sterile packing.
- Mar 19, 2024 · Class II · Z-1799-2024: Potential for unsealed sterile packing.
- Feb 7, 2024 · Class II · Z-1316-2024: Medtronic is writing to inform you of incorrect labeling for three manufactured lots of the DLP Vessel Cannulae for the model and lot numbers listed above.

Source page: https://510kreport.com/device/K810820
Methodology: https://510kreport.com/methodology