| Device Type ID | 23 |
| Device Name | Airway, Nasopharyngeal |
| Regulation Description | Nasopharyngeal Airway. |
| Regulation Medical Specialty | Anesthesiology |
| Review Panel | Anesthesiology |
| Premarket Review | Office Of Device Evaluation (ODE) Division Of Anesthesiology, General Hospital, Infection Control, And Dental Devices (DAGRID) Respiratory Devices Branch (RPDB) |
| Submission Type | 510(K) Exempt |
| CFR Regulation Number | 868.5100 [🔎] |
| FDA Device Classification | Class 1 Medical Device |
| Product Code | BTQ |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 23 |
| Device | Airway, Nasopharyngeal |
| Product Code | BTQ |
| FDA Device Classification | Class 1 Medical Device |
| Regulation Description | Nasopharyngeal Airway. |
| CFR Regulation Number | 868.5100 [🔎] |
| Device Problems | |
|---|---|
Detachment Of Device Or Device Component | 3 |
Component Missing | 2 |
Appropriate Term/Code Not Available | 1 |
Adverse Event Without Identified Device Or Use Problem | 1 |
Device Markings / Labelling Problem | 1 |
Material Too Rigid Or Stiff | 1 |
Material Separation | 1 |
| Total Device Problems | 10 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Teleflex Medical | II | Mar-21-2017 |