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
Declining activity - 0 submissions in the last 2 years vs 1 in the prior period

FDA 510(k) Cleared Tubing, Long Term Support Greater Than 6 Hours Devices (Product Code QWF)

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

About Product Code QWF - Regulatory Context

510(k) Submission Activity

1 total 510(k) submissions under product code QWF since 2023, with 1 receiving FDA clearance (average review time: 190 days).

Submission volume has declined in recent years - 0 submissions in the last 24 months compared to 1 in the prior period.

QWF devices are reviewed by the Cardiovascular panel. Browse all Cardiovascular devices →