| Device Type ID | 24 |
| Device Name | Tube, Tracheal (w/wo Connector) |
| Regulation Description | Tracheal 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 | 868.5730 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | BTR |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | Yes |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 24 |
| Device | Tube, Tracheal (w/wo Connector) |
| Product Code | BTR |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Tracheal Tube. |
| CFR Regulation Number | 868.5730 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
COOK, INC. | ||
GRANTED | 1 | |
SUBSTANTIALLY EQUIVALENT | 1 | |
COVIDIEN | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
DAVIS MEDICAL | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
ETVIEW LTD. | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
SUZHOU WEIKANG MEDICAL APPARATUS CO.,LTD | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
TELEFLEX MEDICAL | ||
SUBSTANTIALLY EQUIVALENT | 3 | |
TELEFLEX MEDICAL, INC. | ||
SUBSTANTIALLY EQUIVALENT | 3 | |
TIANJIN MEDIS MEDICAL DEVICE CO., LTD. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
WILLIAM COOK | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
WILLIAM COOK EUROPE APS | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
| Device Problems | |
|---|---|
Inflation Problem | 776 |
Leak / Splash | 345 |
Device Contamination With Chemical Or Other Material | 303 |
Air Leak | 271 |
Cuff | 170 |
Disconnection | 168 |
Device Markings / Labelling Problem | 161 |
Detachment Of Device Or Device Component | 112 |
Break | 102 |
Tube | 92 |
Deflation Problem | 91 |
Kinked | 89 |
Connection Problem | 84 |
Occlusion Within Device | 78 |
Device Operates Differently Than Expected | 77 |
Detachment Of Device Component | 58 |
Material Deformation | 56 |
Difficult To Advance | 55 |
Material Separation | 47 |
Packaging Problem | 45 |
Gas Leak | 44 |
Insufficient Information | 33 |
Pressure Problem | 33 |
Human-Device Interface Problem | 32 |
Loose Or Intermittent Connection | 31 |
Obstruction Of Flow | 29 |
Balloon | 28 |
Burst Container Or Vessel | 28 |
Contamination During Use | 28 |
Partial Blockage | 28 |
Fitting Problem | 27 |
Device Packaging Compromised | 27 |
Material Integrity Problem | 27 |
Bent | 27 |
Material Puncture / Hole | 26 |
Device Contaminated During Manufacture Or Shipping | 26 |
Material Rupture | 26 |
Appropriate Term/Code Not Available | 25 |
Material Split, Cut Or Torn | 25 |
Adverse Event Without Identified Device Or Use Problem | 24 |
Tear, Rip Or Hole In Device Packaging | 24 |
Inadequate Instructions For Healthcare Professional | 22 |
Defective Device | 22 |
Contamination Of Device Ingredient Or Reagent | 22 |
Hole In Material | 22 |
Torn Material | 20 |
Connector | 19 |
Component Missing | 18 |
Defective Component | 17 |
Crack | 14 |
Unsealed Device Packaging | 13 |
Fracture | 13 |
Product Quality Problem | 12 |
Inadequacy Of Device Shape And/or Size | 12 |
Failure To Disconnect | 12 |
Device Damaged Prior To Use | 11 |
Difficult To Insert | 10 |
Pilot Balloon Valve | 10 |
Physical Resistance | 10 |
Delivered As Unsterile Product | 10 |
Flange | 9 |
Material Too Rigid Or Stiff | 9 |
Fluid Leak | 9 |
Split | 9 |
Ejection Problem | 8 |
Device Alarm System | 8 |
System | 8 |
Deformation Due To Compressive Stress | 8 |
Peeled / Delaminated | 7 |
Decrease In Pressure | 7 |
Mechanical Problem | 7 |
Device Dislodged Or Dislocated | 6 |
Unraveled Material | 6 |
Material Twisted / Bent | 6 |
Misassembled | 5 |
Delamination | 5 |
Use Of Device Problem | 5 |
Suction Problem | 5 |
Material Perforation | 5 |
Manufacturing, Packaging Or Shipping Problem | 5 |
Material Fragmentation | 5 |
Separation Failure | 4 |
Off-Label Use | 4 |
Device-Device Incompatibility | 4 |
Unintended Movement | 4 |
Cut In Material | 4 |
Nonstandard Device | 4 |
Stylet | 4 |
Cannula | 4 |
Infusion Or Flow Problem | 4 |
Migration Or Expulsion Of Device | 4 |
Valve | 4 |
Device Operational Issue | 3 |
Illegible Information | 3 |
Ventilation Problem In Device Environment | 3 |
Collapse | 3 |
Adapter (Adaptor) | 3 |
Output Problem | 3 |
Incorrect Device Or Component Shipped | 3 |
Joint | 3 |
| Total Device Problems | 4277 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Halyard Health | I | Dec-24-2014 |
| 2 | Parker Medical | II | Jul-19-2016 |
| 3 | Smiths Medical ASD, Inc. | I | Aug-28-2014 |
| 4 | Smiths Medical ASD, Inc. | I | Jun-11-2014 |
| 5 | Stryker Sustainability Solutions | II | May-09-2016 |
| 6 | Teleflex Medical | II | Feb-09-2017 |
| 7 | Teleflex Medical | II | Nov-09-2016 |
| 8 | Teleflex Medical | II | Jun-09-2016 |
| 9 | Teleflex Medical | II | Feb-10-2015 |
| 10 | Teleflex Medical | II | Dec-12-2014 |
| 11 | Teleflex Medical | II | Jun-23-2014 |
| 12 | Teleflex Medical | I | Feb-21-2014 |
| 13 | Teleflex, Inc. | II | Feb-17-2015 |