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