MAUDE manufacturer profile
INFRAREDX, INC. · OGZ
MAUDE profile for Catheter, Intravascular, Plaque Morphology Evaluation
Key facts
| Manufacturer | INFRAREDX, INC. |
|---|---|
| Manufacturer group | INFRAREDX, INC. |
| Product code | OGZ |
| Product code name | Catheter, Intravascular, Plaque Morphology Evaluation |
At a glance
- 10–99 MAUDE reports
- 1–9 Injury reports
- 10–99 Malfunction reports
- 10–99 Problems flagged by Orca1 signal analytics
- No Consequences Or Impact To Patient, Difficult to Remove, No Known Impact Or Consequence To Patient, Foreign Body In Patient, Positioning Problem, Unspecified Vascular Problem, Activation, Positioning or Separation Problem, Failure to Advance Most reported problems
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About MAUDE manufacturer and product code profiles
Manufacturer profiles aggregate MAUDE reports for one manufacturer within one product code, the level at which device safety signals are usually reviewed.
Source: U.S. Food and Drug Administration (FDA), MAUDE database; aggregation by Orca1