QCX — Retrograde Intubation Set Class II
FDA product code QCX covers "Retrograde Intubation Set", a Class II medical device regulated under 21 CFR 868.5095. Submissions are reviewed by the Anesthesiology panel. At least 1 recent 510(k) clearance has been granted under this product code.
Classification Details
- Product Code
- QCX
- Device Class
- Class II
- Regulation Number
- 868.5095
- Submission Type
- Review Panel
- AN
- Medical Specialty
- Anesthesiology
- Implant
- No
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).
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| DEN170055 | cook incorporated | Retrograde Intubation Set | December 12, 2018 |