| Device Type ID | 828 |
| Device Name | System, Phonocatheter, Intracavitary |
| Regulation Description | Intracavitary Phonocatheter System. |
| Regulation Medical Specialty | Cardiovascular |
| Review Panel | Cardiovascular |
| Premarket Review | Office Of Device Evaluation (ODE) Division Of Cardiovascular Devices (DCD) Interventional Cardiology Devices Branch (ICDB) |
| Submission Type | 510(k) |
| CFR Regulation Number | 870.1270 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | DXW |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Eligible For Accredited Persons Expansion Pilot Program |
| Device Type ID | 828 |
| Device | System, Phonocatheter, Intracavitary |
| Product Code | DXW |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Intracavitary Phonocatheter System. |
| CFR Regulation Number | 870.1270 [🔎] |