| Device Type ID | 837 |
| Device Name | Injector, Contrast Medium, Automatic |
| Regulation Description | Angiographic Injector And Syringe. |
| Regulation Medical Specialty | Cardiovascular |
| Review Panel | Cardiovascular |
| Premarket Review | Office Of Device Evaluation (ODE) Division Of Cardiovascular Devices (DCD) Cardiac Diagnostics Devices Branch (CDDB) |
| Submission Type | 510(k) |
| CFR Regulation Number | 870.1650 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | IZQ |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Eligible For Accredited Persons Expansion Pilot Program |
| Device Type ID | 837 |
| Device | Injector, Contrast Medium, Automatic |
| Product Code | IZQ |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Angiographic Injector And Syringe. |
| CFR Regulation Number | 870.1650 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
MALLINCKRODT HOSPITAL PRODUCTS, INC | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
ULRICH GMBH & CO. KG | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
| Device Problems | |
|---|---|
Break | 1 |
Inaccurate Flow Rate | 1 |
Material Integrity Problem | 1 |
Device Operates Differently Than Expected | 1 |
Adverse Event Without Identified Device Or Use Problem | 1 |
Physical Property Issue | 1 |
| Total Device Problems | 6 |