The following data is part of a De Novo classification by Cook Incorporated with the FDA for Retrograde Intubation Set.
| DeNovo ID | DEN170055 |
| Device Name: | Retrograde Intubation Set |
| Classification | Tube, Tracheal (w/wo Connector) |
| Applicant | Cook Incorporated 750 Daniels Way Bloomington, ID 47404 |
| Contact | Hui Ouyang |
| Product Code | BTR |
| CFR Regulation Number | 868.5730 [🔎] |
| Decision | Granted (DENG) |
| 510(k) Premarket Notification | Device Classification Under Section 513(f)(2)(de Novo) // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Lin |
| Review Advisory Board | Anesthesiology |
| Classification Advisory | Anesthesiology |
| Type | Direct |
| Date Received | 2017-09-25 |
| Decision Date | 2018-12-12 |
| Reclassification Order: | Reclassification Order |