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 (all years, FDA)

1 (all years; only the last 3 years are listed here)

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).