QCX

Retrograde Intubation Set

Product code
QCX
Device name
Retrograde Intubation Set
Device class
Class 2
21 CFR
21 CFR 868.5095
Medical specialty
Anesthesiology
Marketing pathway
510(K)
Flag
Third-party review eligible
510(k) clearances (last 3 years)
1

FDA classification definition

A retrograde intubation device is a prescription device used to perform retrograde intubation via the cricothyroid membrane. The device may contain or be labeled for use with guidewires and intubating catheters, in addition to needles (21 CFR 8685090), syringe (21 CFR 880.5860), and hemostats (21 CFR 878.4800).

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

Official FDA classification page: QCX
Classification and pathway per current FDA publications. Data from openFDA (CC0).