# K233702: SMARxT Tubing and Connectors

- Pathway: 510(k) (Traditional)
- Applicant: LivaNova USA, Inc.
- Decided: Aug 8, 2024 after 265 days
- Product code: DWE (Tubing, Pump, Cardiopulmonary Bypass)
- Device class: 2
- Regulation: 21 CFR 870.4390
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K981613 (1998). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K981613: Cobe Smarxt Tubing and Connectors, Cobe Cardiovascular, Inc. (1998) Summary page 4.

## Indications for use
The SMARxT Tubing and Connectors, a part of the Heart/Lung Perfusion Pack, are intended to be used in surgical procedures requiring extracorporeal support for periods of up to six hours.

Source page: https://510kreport.com/device/K233702
Methodology: https://510kreport.com/methodology