# K981613: Cobe Smarxt Tubing and Connectors

- Pathway: 510(k) (Traditional)
- Applicant: Cobe Cardiovascular, Inc.
- Decided: Oct 26, 1998 after 173 days
- Product code: DWE (Tubing, Pump, Cardiopulmonary Bypass)
- Device class: 2
- Regulation: 21 CFR 870.4390
- Recalls of this device: 18 (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. The FDA summary names its predicate without a number.
- (no number) COBE® Tubing and Connectors: named in the summary without a submission number

## Most influential descendants
- K233702: SMARxT Tubing and Connectors (2024), 0 descendants of its own

## Recalls of this device
- Jul 3, 2019 · Class III · Z-1389-2020: Perfusion tubing pack was packaged with the incorrect cuvette.
- Dec 19, 2017 · Class III · Z-0664-2018: The product is labeled with the incorrect expiration date.
- Jun 29, 2017 · Class II · Z-2798-2017: Medtronic informed LivaNova that some of their DLP Pressure Disposable Display Sets are packaged in pouches which may have small pinholes (approximately 1mm or less in diameter). The result is a poten
- Jun 29, 2017 · Class II · Z-2794-2017: Medtronic informed LivaNova that some of their DLP Pressure Disposable Display Sets are packaged in pouches which may have small pinholes (approximately 1mm or less in diameter). The result is a poten
- Jun 29, 2017 · Class II · Z-2790-2017: Medtronic informed LivaNova that some of their DLP Pressure Disposable Display Sets are packaged in pouches which may have small pinholes (approximately 1mm or less in diameter). The result is a poten
- Jun 29, 2017 · Class II · Z-2784-2017: Medtronic informed LivaNova that some of their DLP Pressure Disposable Display Sets are packaged in pouches which may have small pinholes (approximately 1mm or less in diameter). The result is a poten
- Jun 29, 2017 · Class II · Z-2789-2017: Medtronic informed LivaNova that some of their DLP Pressure Disposable Display Sets are packaged in pouches which may have small pinholes (approximately 1mm or less in diameter). The result is a poten
- Jun 29, 2017 · Class II · Z-2795-2017: Medtronic informed LivaNova that some of their DLP Pressure Disposable Display Sets are packaged in pouches which may have small pinholes (approximately 1mm or less in diameter). The result is a poten
- Jun 29, 2017 · Class II · Z-2786-2017: Medtronic informed LivaNova that some of their DLP Pressure Disposable Display Sets are packaged in pouches which may have small pinholes (approximately 1mm or less in diameter). The result is a poten
- Jun 29, 2017 · Class II · Z-2791-2017: Medtronic informed LivaNova that some of their DLP Pressure Disposable Display Sets are packaged in pouches which may have small pinholes (approximately 1mm or less in diameter). The result is a poten
- Jun 29, 2017 · Class II · Z-2787-2017: Medtronic informed LivaNova that some of their DLP Pressure Disposable Display Sets are packaged in pouches which may have small pinholes (approximately 1mm or less in diameter). The result is a poten
- Jun 29, 2017 · Class II · Z-2797-2017: Medtronic informed LivaNova that some of their DLP Pressure Disposable Display Sets are packaged in pouches which may have small pinholes (approximately 1mm or less in diameter). The result is a poten
- Jun 29, 2017 · Class II · Z-2788-2017: Medtronic informed LivaNova that some of their DLP Pressure Disposable Display Sets are packaged in pouches which may have small pinholes (approximately 1mm or less in diameter). The result is a poten
- Jun 29, 2017 · Class II · Z-2796-2017: Medtronic informed LivaNova that some of their DLP Pressure Disposable Display Sets are packaged in pouches which may have small pinholes (approximately 1mm or less in diameter). The result is a poten
- Jun 29, 2017 · Class II · Z-2793-2017: Medtronic informed LivaNova that some of their DLP Pressure Disposable Display Sets are packaged in pouches which may have small pinholes (approximately 1mm or less in diameter). The result is a poten
- Jun 29, 2017 · Class II · Z-2792-2017: Medtronic informed LivaNova that some of their DLP Pressure Disposable Display Sets are packaged in pouches which may have small pinholes (approximately 1mm or less in diameter). The result is a poten
- Jun 29, 2017 · Class II · Z-2785-2017: Medtronic informed LivaNova that some of their DLP Pressure Disposable Display Sets are packaged in pouches which may have small pinholes (approximately 1mm or less in diameter). The result is a poten
- Jun 29, 2017 · Class II · Z-2783-2017: Medtronic informed LivaNova that some of their DLP Pressure Disposable Display Sets are packaged in pouches which may have small pinholes (approximately 1mm or less in diameter). The result is a poten

## Indications for use
COBE® SMAR,T™ Tubing and Connectors are intended to be used in surgical procedures requiring extracorporeal support for periods of up to six hours.

Source page: https://510kreport.com/device/K981613
Methodology: https://510kreport.com/methodology