Definition: This Product Code Has Been Established In Accordance With The May 20, 1997, Guidance Entitled, Convenience Kits Interim Regulatory Guidance, Found At Www.Fda.Gov/cdrh/ode/convkit.Html. This Type Of Convenience Kit, As Listed In The Guidance Above, Is
| Device Type ID | 928 |
| Device Name | Angiography/angioplasty Kit |
| Physical State | This Product Code Has Been Established In Accordance With The May 20, 1997, Guidance Entitled, Convenience Kits Interim Regulatory Guidance, Found At Www.fda.gov/cdrh/ode/convkit.html. This Type Of Convenience Kit, As Listed In The Guidance Above, Is |
| Technical Method | This Product Code Has Been Established In Accordance With The May 20, 1997, Guidance Entitled, Convenience Kits Interim Regulatory Guidance, Found At Www.fda.gov/cdrh/ode/convkit.html. This Type Of Convenience Kit, As Listed In The Guidance Above, Is |
| Target Area | This Product Code Has Been Established In Accordance With The May 20, 1997, Guidance Entitled, Convenience Kits Interim Regulatory Guidance, Found At Www.fda.gov/cdrh/ode/convkit.html. This Type Of Convenience Kit, As Listed In The Guidance Above, Is |
| 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 | Enforcement Discretion |
| CFR Regulation Number | 870.1650 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | OEQ |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 928 |
| Device | Angiography/angioplasty Kit |
| Product Code | OEQ |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Angiographic Injector And Syringe. |
| CFR Regulation Number | 870.1650 [🔎] |
| Device Problems | |
|---|---|
Material Integrity Problem | 4 |
Crack | 3 |
Break | 2 |
Fracture | 2 |
Connection Problem | 1 |
Fluid Leak | 1 |
Mechanical Problem | 1 |
Loose Or Intermittent Connection | 1 |
Manufacturing, Packaging Or Shipping Problem | 1 |
Leak / Splash | 1 |
Device Misassembled During Manufacturing / Shipping | 1 |
Device Contamination With Chemical Or Other Material | 1 |
Device Contaminated During Manufacture Or Shipping | 1 |
Material Deformation | 1 |
Material Fragmentation | 1 |
Unsealed Device Packaging | 1 |
Material Separation | 1 |
Material Protrusion / Extrusion | 1 |
| Total Device Problems | 25 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Angiodynamics Inc. (Navilyst Medical Inc.) | II | Apr-17-2018 |
| 2 | Customed, Inc | II | Apr-14-2016 |
| 3 | Customed, Inc | II | Sep-03-2015 |
| 4 | Customed, Inc | I | Dec-16-2014 |
| 5 | Customed, Inc | I | Aug-29-2014 |
| 6 | Navilyst Medical, Inc | II | Feb-26-2015 |