Device Type ID | 2174 |
Device Name | Stent, Metallic, Expandable, Duodenal |
Regulation Description | Esophageal Prosthesis. |
Regulation Medical Specialty | General & Plastic Surgery |
Review Panel | Gastroenterology/Urology |
Premarket Review | Office Of Device Evaluation (ODE) Division Of Reproductive, Gastro-Renal, And Urological Devices (DRGUD) Renal Devices Branch (RNDB) |
Submission Type | 510(k) |
CFR Regulation Number | 878.3610 [🔎] |
FDA Device Classification | Class 2 Medical Device |
Product Code | MUM |
GMP Exempt | No |
Summary MR | Ineligible |
Implanted Device | Yes |
Life Support Device | No |
Third Party Review | Not Third Party Eligible |
Device Type ID | 2174 |
Device | Stent, Metallic, Expandable, Duodenal |
Product Code | MUM |
FDA Device Classification | Class 2 Medical Device |
Regulation Description | Esophageal Prosthesis. |
CFR Regulation Number | 878.3610 [🔎] |
Premarket Reviews | ||
---|---|---|
Manufacturer | Decision | |
COOK IRELAND LTD. | ||
SUBSTANTIALLY EQUIVALENT | 1 |
Device Problems | |
---|---|
Stent | 68 |
Break | 44 |
Fracture | 43 |
Activation, Positioning Or Separation Problem | 38 |
Migration Or Expulsion Of Device | 28 |
Adverse Event Without Identified Device Or Use Problem | 22 |
Delivery System Failure | 22 |
Positioning Problem | 19 |
Activation Failure Including Expansion Failures | 15 |
Premature Activation | 11 |
Insufficient Information | 9 |
Partial Blockage | 8 |
Appropriate Term/Code Not Available | 7 |
Catheter | 6 |
Material Deformation | 6 |
Detachment Of Device Or Device Component | 5 |
Kinked | 5 |
Difficult To Remove | 4 |
Difficult Or Delayed Positioning | 3 |
Occlusion Within Device | 2 |
Material Frayed | 1 |
Delivery System Issue, No Description | 1 |
Device Deployer | 1 |
Tip Breakage | 1 |
Migration | 1 |
Difficult To Advance | 1 |
Safety Interlock | 1 |
Positioning Failure | 1 |
Material Fragmentation | 1 |
Off-Label Use | 1 |
Total Device Problems | 375 |