DEN170055 is an FDA 510(k) submission for the Retrograde Intubation Set. This device is classified as a Retrograde Intubation Set (Class II - Special Controls, product code QCX).
Submitted by Cook Incorporated (Bloomington, US). The FDA issued a Not Cleared (DENG) decision on December 12, 2018.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.5095. 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) Number | DEN170055 FDA.gov |
| FDA Decision | Not Cleared Not Substantially Equivalent (DENG) |
| Date Received | September 25, 2017 |
| Decision Date | December 12, 2018 |
| Days to Decision | 443 days |
| Submission Type | Direct |
| Review Panel | Anesthesiology (AN) |
| Summary | — |
| Product Code | QCX — Retrograde Intubation Set |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 868.5095 |
| 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). |