| Device Type ID | 98 |
| Device Name | Device, Fixation, Tracheal Tube |
| Regulation Description | Tracheal Tube Fixation Device. |
| 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) Exempt |
| CFR Regulation Number | 868.5770 [🔎] |
| FDA Device Classification | Class 1 Medical Device |
| Product Code | CBH |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 98 |
| Device | Device, Fixation, Tracheal Tube |
| Product Code | CBH |
| FDA Device Classification | Class 1 Medical Device |
| Regulation Description | Tracheal Tube Fixation Device. |
| CFR Regulation Number | 868.5770 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
APPLIED MEDICAL TECHNOLOGY, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
| Device Problems | |
|---|---|
No Apparent Adverse Event | 5 |
Loss Of Or Failure To Bond | 4 |
Device Operates Differently Than Expected | 2 |
Adverse Event Without Identified Device Or Use Problem | 1 |
Adhesive | 1 |
Material Separation | 1 |
Manufacturing, Packaging Or Shipping Problem | 1 |
Break | 1 |
Insufficient Information | 1 |
| Total Device Problems | 17 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Dale Medical Products, Inc. | II | May-03-2017 |