| Device Type ID | 777 |
| Device Name | Prosthesis, Vascular Graft, Of 6mm And Greater Diameter |
| Regulation Description | Vascular Graft Prosthesis. |
| Regulation Medical Specialty | Cardiovascular |
| Review Panel | Cardiovascular |
| Premarket Review | Office Of Device Evaluation (ODE) Division Of Cardiovascular Devices (DCD) Vascular Surgery Devices Branch (VSDB) |
| Submission Type | 510(k) |
| CFR Regulation Number | 870.3450 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | DSY |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | Yes |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
|
| Device Type ID | 777 |
| Device | Prosthesis, Vascular Graft, Of 6mm And Greater Diameter |
| Product Code | DSY |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Vascular Graft Prosthesis. |
| CFR Regulation Number | 870.3450 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
MAQUET CARDIOVASCULAR, LLC | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
MAQUET, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
MERIT MEDICAL SYSTEMS, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
TERUMO CARDIOVASCULAR SYSTEMS CORP. | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
VASCULAR FLOW TECHNOLOGIES LIMITED | ||
SUBSTANTIALLY EQUIVALENT | 3 | |
VASCUTEK LTD. | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
| Device Problems | |
|---|---|
Appropriate Term/Code Not Available | 123 |
Manufacturing, Packaging Or Shipping Problem | 107 |
Occlusion Within Device | 66 |
Insufficient Information | 58 |
Adverse Event Without Identified Device Or Use Problem | 55 |
Device Operates Differently Than Expected | 49 |
Leak / Splash | 49 |
Torn Material | 48 |
Complete Blockage | 35 |
Obstruction Of Flow | 24 |
Hole In Material | 20 |
Material Integrity Problem | 17 |
Material Puncture / Hole | 11 |
Unraveled Material | 10 |
Material Separation | 10 |
Delamination | 9 |
Migration Or Expulsion Of Device | 8 |
Peeled / Delaminated | 8 |
Material Deformation | 7 |
Break | 7 |
Patient-Device Incompatibility | 7 |
Material Split, Cut Or Torn | 7 |
Material Frayed | 6 |
Product Quality Problem | 6 |
Material Perforation | 5 |
Material Rupture | 4 |
Entrapment Of Device | 3 |
Mechanical Problem | 3 |
Partial Blockage | 3 |
Detachment Of Device Component | 3 |
Contamination During Use | 3 |
Use Of Device Problem | 3 |
Shipping Damage Or Problem | 2 |
Activation, Positioning Or Separation Problem | 2 |
Degraded | 2 |
Material Discolored | 2 |
Improper Or Incorrect Procedure Or Method | 2 |
Fracture | 2 |
Human-Device Interface Problem | 2 |
Infusion Or Flow Problem | 2 |
Sticking | 2 |
Device Contamination With Biological Material | 2 |
Device Contamination With Chemical Or Other Material | 2 |
Device Packaging Compromised | 2 |
Device Handling Problem | 2 |
Microbial Contamination Of Device | 2 |
Fluid Leak | 2 |
Stretched | 2 |
Flaked | 2 |
Kinked | 2 |
Loose Or Intermittent Connection | 1 |
Material Distortion | 1 |
Material Erosion | 1 |
Fiber | 1 |
Disconnection | 1 |
Fungus In Device Environment | 1 |
Malposition Of Device | 1 |
Device Markings / Labelling Problem | 1 |
Detachment Of Device Or Device Component | 1 |
Improper Flow Or Infusion | 1 |
Nonstandard Device | 1 |
Shelf Life Exceeded | 1 |
Filling Problem | 1 |
Material Protrusion / Extrusion | 1 |
Off-Label Use | 1 |
Out-Of-Box Failure | 1 |
Device Issue | 1 |
Device Damaged By Another Device | 1 |
Biological Environmental Factor | 1 |
Inadequacy Of Device Shape And/or Size | 1 |
Accessory Incompatible | 1 |
Surgical Graft | 1 |
Device Operational Issue | 1 |
Difficult To Remove | 1 |
Problem With Removal Of Enzymatic Cleaner | 1 |
Device Inoperable | 1 |
Structural Problem | 1 |
Component Missing | 1 |
Label | 1 |
Biofilm Coating In Device | 1 |
Coagulation In Device Or Device Ingredient | 1 |
| Total Device Problems | 841 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Bard Peripheral Vascular Inc | II | Feb-09-2016 |
| 2 | Vascutek, Ltd. | II | Aug-18-2014 |