Retrograde Intubation Set
The Retrograde Intubation Set is a prescription device used to perform retrograde intubation via the cricothyroid membrane, and may contain or be labeled for use with guidewires and intubating catheters, needles, syringes, and hemostats. It is classified as FDA Class 2, requiring 510(k) premarket notification, and is eligible for third-party review. The product code is QCX under regulation 868.5095 in the Anesthesiology specialty. It is not an implant and is not life-sustaining.
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Basic Information
- Product Code
- QCX
- Device Class
- FDA class 2
- Regulation Number
- 868.5095
- Medical Specialty
- Anesthesiology
- Review Panel
- AN
- Submission Type
- 1
Device Characteristics
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).
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 1 510(k) clearance via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| DEN170055 | Retrograde Intubation Set | Dec 12, 2018 | Unknown | Cook Incorporated |
FEI Numbers
This FDA classification entry is associated with 2 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 2 registration numbers. Click on an entry to view related FDA registrations.