Definition: Catheter Used For Delivery Of A Sensing Modality To A Coronary Or Peripheral Artery Region For Determination Of Atherosclerotic Plaque Characteristics. For Examination Of Morphologic Features Of Coronary Or Peripheral Artery Lesions Or Plaques.
| Device Type ID | 949 |
| Device Name | Catheter, Intravascular, Plaque Morphology Evaluation |
| Physical State | Flexible Intravascular Catheter With Plaque Diagnostic Modality At The Tip. |
| Technical Method | The Device Is Inserted Into The Arterial Segment Of Interest, And Using Its Sensing Technology, Obtains Information On The Characteristics Of The Arterial Wall. The Characteristics Are Captured Digitally And Filtered With A Software Algorithm, And Th |
| Target Area | Coronary Or Peripheral Arteries. |
| 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 | OGZ |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 949 |
| Device | Catheter, Intravascular, Plaque Morphology Evaluation |
| Product Code | OGZ |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Diagnostic Intravascular Catheter. |
| CFR Regulation Number | 870.1200 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
INFRAREDX, INC. | ||
SUBSTANTIALLY EQUIVALENT | 3 | |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Infraredx, Inc. | II | Jan-03-2017 |