Definition: For Intracardiac And Intraluminal Visualization Of Cardiovascular Anatomy And Physiology.
| Device Type ID | 957 |
| Device Name | Reprocessed Intravascular Ultrasound Catheter |
| Physical State | Catheter With Ultrasound Sensors That Is Used With An Imaging System To Display Ultrasound Image. |
| Technical Method | Catheter With Ultrasound Sensors That Is Used With An Imaging System To Display Ultrasound Image. |
| Target Area | Cardiovascular Anatomy And Physiology. |
| 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 | OWQ |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
|
| Device Type ID | 957 |
| Device | Reprocessed Intravascular Ultrasound Catheter |
| Product Code | OWQ |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Diagnostic Intravascular Catheter. |
| CFR Regulation Number | 870.1200 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
INNOVATIVE HEALTH, LLC. | ||
SUBSTANTIALLY EQUIVALENT | 3 | |
STERILMED | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
STERILMED, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
| Device Problems | |
|---|---|
Adverse Event Without Identified Device Or Use Problem | 8 |
Poor Gas Exchange | 1 |
Activation, Positioning Or Separation Problem | 1 |
| Total Device Problems | 10 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | STERILMED, INC. | II | Oct-09-2014 |