| Device Type ID | 99 |
| Device Name | Tube, Tracheal/bronchial, Differential Ventilation (w/wo Connector) |
| Regulation Description | Tracheal/bronchial Differential Ventilation Tube. |
| 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 | 868.5740 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | CBI |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | Yes |
| Third Party Review | Not Third Party Eligible |
|
| Device Type ID | 99 |
| Device | Tube, Tracheal/bronchial, Differential Ventilation (w/wo Connector) |
| Product Code | CBI |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Tracheal/bronchial Differential Ventilation Tube. |
| CFR Regulation Number | 868.5740 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
COOK, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
ETVIEW LTD. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
TELEFLEX MEDICAL | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
TELEFLEX MEDICAL, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
| Device Problems | |
|---|---|
Leak / Splash | 40 |
Inflation Problem | 32 |
Break | 16 |
Output Problem | 14 |
Air Leak | 10 |
Cap | 10 |
Device Operates Differently Than Expected | 8 |
Cuff | 8 |
Tube | 7 |
Device Dislodged Or Dislocated | 6 |
Deflation Problem | 5 |
Connection Problem | 5 |
Material Twisted / Bent | 5 |
Hole In Material | 5 |
Crack | 5 |
Kinked | 5 |
Fitting Problem | 4 |
Suction Problem | 4 |
Gas Leak | 3 |
Port | 3 |
Material Separation | 3 |
System | 3 |
Device Alarm System | 3 |
Disconnection | 3 |
Device Markings / Labelling Problem | 2 |
Device Contamination With Chemical Or Other Material | 2 |
Decrease In Pressure | 2 |
Material Deformation | 2 |
Pressure Problem | 2 |
Bent | 2 |
Material Split, Cut Or Torn | 2 |
Adverse Event Without Identified Device Or Use Problem | 2 |
Label | 1 |
Component Missing | 1 |
Burst Container Or Vessel | 1 |
Physical Resistance | 1 |
Unintended Movement | 1 |
Partial Blockage | 1 |
Device Contaminated During Manufacture Or Shipping | 1 |
Inaccurate Information | 1 |
Device Issue | 1 |
Separation Failure | 1 |
Component Or Accessory Incompatibility | 1 |
Material Too Rigid Or Stiff | 1 |
Complete Blockage | 1 |
Difficult To Advance | 1 |
Manufacturing, Packaging Or Shipping Problem | 1 |
Positioning Problem | 1 |
Difficult To Insert | 1 |
Loose Or Intermittent Connection | 1 |
Material Rupture | 1 |
Labelling, Instructions For Use Or Training Problem | 1 |
Difficult To Position | 1 |
Packaging Problem | 1 |
Separation Problem | 1 |
| Total Device Problems | 246 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Parker Medical | II | Mar-03-2017 |
| 2 | Teleflex Medical | I | Aug-20-2015 |