QWF · Class II · 21 CFR 870.4100

FDA Product Code QWF: Tubing, Long Term Support Greater Than 6 Hours

The Tubing And Accessories Are Intended To Connect Perfusion Devices And Circulate Blood As Part Of Extracorporeal Membrane Oxygenation Lasting Longer Than 6 Hours.

Leading manufacturers include Medtronic, Inc..

1
Total
1
Cleared
190d
Avg days
2023
Since

List of Tubing, Long Term Support Greater Than 6 Hours devices cleared through 510(k)

1 devices
1–1 of 1
Cleared Apr 19, 2023
Tubing and Accessories Sets for Extracorporeal Membrane Oxygenation (ECMO) with Balance™ Biosurface
K223168
Medtronic, Inc.
Cardiovascular · 190d

How to use this database

This page lists all FDA 510(k) submissions for Tubing, Long Term Support Greater Than 6 Hours devices (product code QWF). Click any device to view full submission details, including the decision date, manufacturer information, predicate device, and a link to the official FDA record.

These devices fall under the Cardiovascular FDA review panel. Browse all Cardiovascular devices →