| Device Type ID | 62 |
| Device Name | Tubing, Pressure And Accessories |
| Regulation Description | Pressure Tubing And Accessories. |
| 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 | 868.5860 [🔎] |
| FDA Device Classification | Class 1 Medical Device |
| Product Code | BYX |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 62 |
| Device | Tubing, Pressure And Accessories |
| Product Code | BYX |
| FDA Device Classification | Class 1 Medical Device |
| Regulation Description | Pressure Tubing And Accessories. |
| CFR Regulation Number | 868.5860 [🔎] |
| Device Problems | |
|---|---|
Kinked | 8 |
Component Falling | 6 |
Disconnection | 6 |
Leak / Splash | 6 |
Crack | 5 |
Burst Container Or Vessel | 4 |
Use Of Device Problem | 4 |
Detachment Of Device Or Device Component | 3 |
Insufficient Information | 3 |
Detachment Of Device Component | 3 |
Break | 2 |
Electrical /Electronic Property Problem | 2 |
Adverse Event Without Identified Device Or Use Problem | 2 |
Failure To Deliver | 1 |
Gas Leak | 1 |
Valve | 1 |
Corroded | 1 |
Improper Flow Or Infusion | 1 |
Material Perforation | 1 |
Flaked | 1 |
Device Contamination With Chemical Or Other Material | 1 |
Air Leak | 1 |
Device Issue | 1 |
Human Factors Issue | 1 |
| Total Device Problems | 65 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | A M Systems Inc | II | Oct-16-2018 |