# K822210: Sarns Cardioplegia Cannulae (Var. Types

- Pathway: 510(k) (Traditional)
- Applicant: 3M Health Care, Sarns
- Decided: Aug 24, 1982 after 29 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.
No later device cites it as a predicate yet.
0 of 1 device 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.

## Recalls of this device
- May 16, 2011 · Not classified · Z-2555-2011: The presence of adhesive and/or skiving of plastic material observed inside the distal tip of the cannula, which could lead to particulate and/or decrease in the internal diameter. The plastic skiving
- May 16, 2011 · Not classified · Z-2554-2011: Terumo has discovered several instances of adhesive build-up and or skiving of plastic (plastic flash) inside the distal tip of the Terumo Coronary Ostia Cannula. The defect was discovered during in-h
- May 16, 2011 · Not classified · Z-2556-2011: The presence of adhesive and/or skiving of plastic material observed inside the distal tip of the cannula, which could lead to particulate and/or decrease in the internal diameter. The plastic skiving

Source page: https://510kreport.com/device/K822210
Methodology: https://510kreport.com/methodology