| Device Type ID | 63 |
| Device Name | Connector, Airway (extension) |
| Regulation Description | Airway Connector. |
| 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 | 868.5810 [🔎] |
| FDA Device Classification | Class 1 Medical Device |
| Product Code | BZA |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
|
| Device Type ID | 63 |
| Device | Connector, Airway (extension) |
| Product Code | BZA |
| FDA Device Classification | Class 1 Medical Device |
| Regulation Description | Airway Connector. |
| CFR Regulation Number | 868.5810 [🔎] |
| Device Problems | |
|---|---|
Air Leak | 8 |
Break | 8 |
Crack | 8 |
Disconnection | 7 |
Melted | 7 |
Device Contamination With Chemical Or Other Material | 6 |
Fitting Problem | 5 |
Connector | 5 |
Detachment Of Device Component | 4 |
Hole In Material | 4 |
Material Separation | 3 |
Leak / Splash | 2 |
Connection Problem | 2 |
Adverse Event Without Identified Device Or Use Problem | 1 |
Mount | 1 |
Obstruction Of Flow | 1 |
Device Issue | 1 |
Device Handling Problem | 1 |
Intermittent Loss Of Power | 1 |
Material Fragmentation | 1 |
Material Rupture | 1 |
Stretched | 1 |
Detachment Of Device Or Device Component | 1 |
| Total Device Problems | 79 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | King Systems Corp. | II | Apr-01-2015 |
| 2 | Teleflex Medical Europe Ltd | II | Apr-17-2018 |