Definition: To Measure Pressure Within The Cardiovascular System.
| Device Type ID | 924 |
| Device Name | Catheter, Pressure Monitoring, Cardiac |
| Physical State | Catheter With Sensors. |
| Technical Method | The Catheter Uses Sensors Which Directly Measure The Pressure. |
| Target Area | Cardiovascular System. |
| Regulation Description | Diagnostic Intravascular Catheter. |
| Regulation Medical Specialty | Cardiovascular |
| Review Panel | Cardiovascular |
| Premarket Review | Office Of Device Evaluation (ODE) Division Of Cardiovascular Devices (DCD) Vascular Surgery Devices Branch (VSDB) |
| Submission Type | 510(k) |
| CFR Regulation Number | 870.1200 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | OBI |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 924 |
| Device | Catheter, Pressure Monitoring, Cardiac |
| Product Code | OBI |
| 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 | 4 |
Catheter | 2 |
Insufficient Information | 1 |
| Total Device Problems | 7 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Merit Medical Systems, Inc. | II | Apr-03-2014 |