| Device Type ID | 827 |
| Device Name | Injector And Syringe, Angiographic |
| 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) Interventional Cardiology Devices Branch (ICDB) |
| Submission Type | 510(k) |
| CFR Regulation Number | 870.1650 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | DXT |
| 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 | 827 |
| Device | Injector And Syringe, Angiographic |
| Product Code | DXT |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Angiographic Injector And Syringe. |
| CFR Regulation Number | 870.1650 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
ACIST MEDICAL SYSTEMS | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
ACIST MEDICAL SYSTEMS, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
BOSTON SCIENTIFIC CORPORATION | ||
SUBSTANTIALLY EQUIVALENT | 4 | |
COEUR, INC. | ||
SUBSTANTIALLY EQUIVALENT | 6 | |
DEROYAL | ||
SUBSTANTIALLY EQUIVALENT - KIT | 1 | |
DEROYAL INDUSTRIES, INC. | ||
SUBSTANTIALLY EQUIVALENT - KIT | 1 | |
ECOMED SOLUTIONS, LLC | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
MEDRAD, INC. / BAYER MEDICAL CARE, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
MERIT MEDICAL SYSTEMS, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
SUBSTANTIALLY EQUIVALENT - KIT | 1 | |
NEMOTO KYORINDO CO., LTD. | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
OSPREY MEDICAL, INC. | ||
SUBSTANTIALLY EQUIVALENT | 12 | |
SHENZHEN BAOAN MEDICAL SUPPLIES CO., LTD | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
WUXI YUSHOU MEDICAL APPLICANCES CO., LTD | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
| Device Problems | |
|---|---|
Adverse Event Without Identified Device Or Use Problem | 64 |
Device Operates Differently Than Expected | 22 |
Material Integrity Problem | 17 |
Device Contamination With Chemical Or Other Material | 15 |
Product Quality Problem | 12 |
Manufacturing, Packaging Or Shipping Problem | 10 |
Inflation Problem | 9 |
Device Dislodged Or Dislocated | 7 |
Defective Device | 7 |
Detachment Of Device Or Device Component | 7 |
Break | 6 |
Insufficient Information | 6 |
Air Leak | 6 |
Use Of Device Problem | 6 |
Device Component Or Accessory | 6 |
Automatic Injection System | 5 |
Material Disintegration | 5 |
Pivot | 5 |
Contamination / Decontamination Problem | 4 |
Device Contaminated During Manufacture Or Shipping | 4 |
Tube | 3 |
Improper Device Output | 3 |
Improper Or Incorrect Procedure Or Method | 2 |
Cable | 2 |
Fracture | 2 |
Patient-Device Incompatibility | 2 |
Device Displays Incorrect Message | 2 |
Syringe | 2 |
Electrical /Electronic Property Problem | 2 |
Unintended System Motion | 2 |
Power Supply | 2 |
Deflation Problem | 2 |
Smoking | 2 |
Physical Property Issue | 2 |
Appropriate Term/Code Not Available | 2 |
Device Handling Problem | 2 |
Device Issue | 2 |
Electrical Shorting | 2 |
Mechanical Problem | 2 |
Connector | 2 |
Disconnection | 2 |
Flaked | 1 |
Interface | 1 |
Overheating Of Device | 1 |
Inaccurate Delivery | 1 |
Fluid Leak | 1 |
Electrical Overstress | 1 |
Inadequate User Interface | 1 |
Missing Value Reason | 1 |
Pressure Tubing | 1 |
Leak / Splash | 1 |
Environmental Particulates | 1 |
Human Factors Issue | 1 |
Plunger | 1 |
Unsealed Device Packaging | 1 |
Sediment, Precipitate Or Deposit In Device Or Device Ingredient | 1 |
No Apparent Adverse Event | 1 |
Manifold | 1 |
Self-Activation Or Keying | 1 |
Connection Problem | 1 |
Sparking | 1 |
Cap | 1 |
Fire | 1 |
Escape | 1 |
Human-Device Interface Problem | 1 |
Infusion Or Flow Problem | 1 |
Electro-Static Discharge | 1 |
Defective Component | 1 |
Device Inoperable | 1 |
Clumping In Device Or Device Ingredient | 1 |
Handpiece | 1 |
| Total Device Problems | 297 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Acist Medical Systems | II | Feb-02-2016 |
| 2 | Bayer Healthcare | II | Sep-08-2016 |
| 3 | Bayer Healthcare | II | Jul-19-2016 |
| 4 | Bayer Healthcare | II | Sep-16-2015 |
| 5 | Bayer Medical Care, Inc. | II | Jan-15-2019 |
| 6 | Bracco Injeneering S.A. | II | Dec-21-2018 |
| 7 | Medrad Inc Dba Bayer R&I | II | May-28-2015 |