QWF

Tubing, Long Term Support Greater Than 6 Hours

Product code: QWF
Device name: Tubing, Long Term Support Greater Than 6 Hours
Device class: Class 2
21 CFR: 21 CFR 870.4100
Medical specialty: Cardiovascular
Marketing pathway: 510(K)
Flag: Life-sustaining / life-supporting
510(k) clearances (all years, FDA): 1 (all years; only the last 3 years are listed here)

FDA classification definition

The tubing and accessories are intended to connect perfusion devices and circulate blood as part of extracorporeal membrane oxygenation lasting longer than 6 hours.

Definition text from the FDA device classification database (U.S. federal government work, public domain).

Official FDA classification page: QWF

Classification and pathway per current FDA publications. Data from openFDA (CC0).