Definition: For Intravascular Visualization Of The Coronary Vessel Lumen And Wall In Patients Who Are Candidates For Transluminal Interventional Procedures.
| Device Type ID | 954 |
| Device Name | Optical Coherence Tomography, Intravascular Catheter |
| Physical State | A Flexible Intravascular Catheter Provides Optical Delivery And Sensing Of Laser Light To Produce Images Of The Vessel Lumen And Wall On Its Associated Imaging System Using Optical Coherence Tomography Technology. |
| Technical Method | A Flexible Intravascular Catheter Provides Optical Delivery And Sensing Of Laser Light To Produce Images Of The Vessel Lumen And Wall On Its Associated Imaging System Using Optical Coherence Tomography Technology. |
| Target Area | Coronary Vasculature |
| Regulation Description | Diagnostic Intravascular Catheter. |
| 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 | 870.1200 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | ORD |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 954 |
| Device | Optical Coherence Tomography, Intravascular Catheter |
| Product Code | ORD |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Diagnostic Intravascular Catheter. |
| CFR Regulation Number | 870.1200 [🔎] |
| Device Problems | |
|---|---|
Adverse Event Without Identified Device Or Use Problem | 10 |
Entrapment Of Device | 5 |
Positioning Problem | 3 |
Sticking | 3 |
Difficult To Remove | 3 |
Material Separation | 2 |
Stretched | 2 |
Folded | 1 |
Physical Resistance | 1 |
Communication Or Transmission Problem | 1 |
Fracture | 1 |
| Total Device Problems | 32 |