| Device Type ID | 222 |
| Device Name | Prosthesis, Tracheal, Expandable |
| Regulation Description | Tracheal Prosthesis. |
| Regulation Medical Specialty | General & Plastic Surgery |
| Review Panel | Anesthesiology |
| Premarket Review | Office Of Device Evaluation (ODE) Division Of Surgical Devices (DSD) General Surgery Devices Branch One - Light Based/Laser (GSDB1) |
| Submission Type | 510(k) |
| CFR Regulation Number | 878.3720 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | JCT |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | Yes |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 222 |
| Device | Prosthesis, Tracheal, Expandable |
| Product Code | JCT |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Tracheal Prosthesis. |
| CFR Regulation Number | 878.3720 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
BOSTON SCIENTIFIC CORP. | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
BOSTON SCIENTIFIC CORPORATION | ||
SUBSTANTIALLY EQUIVALENT | 3 | |
MERIT MEDICAL SYSTEMS, INC | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
MERIT MEDICAL SYSTEMS, INC. | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
| Device Problems | |
|---|---|
Stent | 257 |
Activation, Positioning Or Separation Problem | 133 |
Positioning Problem | 46 |
Activation Failure Including Expansion Failures | 35 |
Break | 34 |
Migration Or Expulsion Of Device | 21 |
Difficult To Remove | 20 |
Adverse Event Without Identified Device Or Use Problem | 20 |
Balloon | 13 |
Catheter | 13 |
Suture | 13 |
Material Deformation | 13 |
Detachment Of Device Component | 12 |
Premature Activation | 11 |
Fracture | 11 |
Material Separation | 10 |
Device Dislodged Or Dislocated | 9 |
Unraveled Material | 8 |
Material Integrity Problem | 6 |
Cover | 6 |
Positioning Failure | 5 |
Bent | 5 |
Failure To Advance | 4 |
Difficult Or Delayed Positioning | 4 |
Detachment Of Device Or Device Component | 4 |
Kinked | 4 |
Loose Or Intermittent Connection | 3 |
Malposition Of Device | 3 |
Occlusion Within Device | 3 |
Tip | 3 |
Obstruction Of Flow | 3 |
Inflation Problem | 3 |
Failure To Capture | 2 |
Contamination During Use | 2 |
Appropriate Term/Code Not Available | 2 |
Component Missing | 2 |
Wire | 2 |
Shaft | 2 |
Device Damaged Prior To Use | 2 |
Difficult To Advance | 2 |
Device Slipped | 2 |
Material Perforation | 2 |
Separation Failure | 2 |
Leak / Splash | 2 |
Inadequacy Of Device Shape And/or Size | 2 |
Sticking | 2 |
Fitting Problem | 2 |
Device-Device Incompatibility | 1 |
Device Contamination With Chemical Or Other Material | 1 |
Incorrect Device Or Component Shipped | 1 |
Partial Blockage | 1 |
Material Fragmentation | 1 |
Device Issue | 1 |
Torn Material | 1 |
Insufficient Information | 1 |
Shelf Life Exceeded | 1 |
Crack | 1 |
Mechanical Problem | 1 |
Device Markings / Labelling Problem | 1 |
Material Rupture | 1 |
Hub | 1 |
Component Falling | 1 |
Entrapment Of Device | 1 |
Misfire | 1 |
Label | 1 |
Deformation Due To Compressive Stress | 1 |
Deflation Problem | 1 |
Retraction Problem | 1 |
Defective Component | 1 |
Tear, Rip Or Hole In Device Packaging | 1 |
Migration | 1 |
Port | 1 |
Valve | 1 |
Device Deployer | 1 |
Burst Container Or Vessel | 1 |
Physical Resistance | 1 |
| Total Device Problems | 794 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Atrium Medical Corporation | II | Jul-07-2017 |
| 2 | Boston Scientific Corporation | II | Apr-25-2016 |
| 3 | EXP Pharmaceutical Services Corp | II | Jul-24-2015 |
| 4 | SPS Sterilization, Inc | II | Sep-13-2018 |