| Device Type ID | 8 |
| Device Name | Cuff, Tracheal Tube, Inflatable |
| Regulation Description | Inflatable Tracheal Tube Cuff. |
| 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) Anesthesiology Devices Branch (ANDB) |
| Submission Type | 510(k) |
| CFR Regulation Number | 868.5750 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | BSK |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | Yes |
| Third Party Review | Eligible For Accredited Persons Expansion Pilot Program |
| Device Type ID | 8 |
| Device | Cuff, Tracheal Tube, Inflatable |
| Product Code | BSK |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Inflatable Tracheal Tube Cuff. |
| CFR Regulation Number | 868.5750 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
HAMILTON | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
HAMILTON MEDICAL AG | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
HOSPITECH RESPIRATION LTD. | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
TELEFLEX MEDICAL | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
TELEFLEX MEDICAL, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
TIANJIN MEDIS MEDICAL DEVICE CO., LTD. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
TRACOE MEDICAL GMBH | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
VORTRAN MEDICAL TECHNOLOGY 1, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
| Device Problems | |
|---|---|
Loose Or Intermittent Connection | 2 |
Inflation Problem | 2 |
Human-Device Interface Problem | 1 |
Connection Problem | 1 |
Fail-Safe Problem | 1 |
Deflation Problem | 1 |
| Total Device Problems | 8 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Hamilton Medical, Inc. | II | Jan-12-2018 |