# K943934: Aortic Arch Cannulas

- Pathway: 510(k) (Traditional)
- Applicant: Sorin Group Italia S.R.L.
- Decided: Jun 2, 1995 after 294 days
- Product code: DWF (Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass)
- Device class: 2
- Regulation: 21 CFR 870.4210
- Recalls of this device: 4 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
7 later devices descend from it; 4 cite it directly.
2 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

## Most influential descendants
- K083111: Impella 5.0 Catheter Family (2009), 3 descendants of its own
- K102726: Cardiohelp System (2011), 2 descendants of its own
- K262052: Tri Stage Venous Cannulae (2026), 0 descendants of its own
- K250937: Venous Return Cannulae (2026), 0 descendants of its own
- K253671: Dual Stage Venous Cannulae (2026), 0 descendants of its own

## Recalls of this device
- Jun 9, 2017 · Class II · Z-2871-2017: Identification of excess plastic on the tip of the cannula.
- Aug 12, 2016 · Class II · Z-2756-2016: Sorin Group USA, Inc. announces a voluntary field for the Aortic Arch Cannula and Coronary Artery Perfusion Cannula With Ballon because the tip of the cannula should be bent at either a 45 or 90 degre
- Jun 22, 2016 · Class II · Z-2147-2016: Sorin Group USA is recalling Aortic Arch Cannulae (part numbers NA-55X7 and NA-55X8) because the distal end may be less than specified. The defective cannula are showing an angle that is about 15-20 d
- Jan 25, 2016 · Class II · Z-0813-2016: Sorin Group initiated field correction for the Dual Stage Venous Return Catheter because the incorrect Instructions For Use (IFU) was packaged in the case.

Source page: https://510kreport.com/device/K943934
Methodology: https://510kreport.com/methodology