DXW · System, Phonocatheter, Intracavitary
Cardiovascular · 21 CFR 870.1270 · Class 2
Overview
| Product Code | DXW |
|---|---|
| Device Name | System, Phonocatheter, Intracavitary |
| Regulation | 21 CFR 870.1270 |
| Device Class | Class 2 |
| Review Panel | Cardiovascular |
| 3rd-Party Reviewable | Yes |
Identification
An intracavitary phonocatheter system is a system that includes a catheter with an acoustic transducer and the associated device that processes the signal from the transducer; this device records bioacoustic phenomena from a transducer placed within the heart, blood vessels, or body cavities.
Classification Rationale
Class II (performance standards).
Recent Cleared Devices (5 of 5)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K972020 | OSCILLOMATE NON-INVASIVE BLOOD PRESSURE MONITOR | Cas Medical Systems, Inc. | May 5, 1998 | SESE |
| K955887 | NEWMED ABP-LITE | Newmed Corp. | Sep 5, 1996 | SESE |
| K802830 | MILLAR MIKRO-TIP CATHETER PHONOTRANS | Millar Instruments, Inc. | Dec 10, 1980 | SESE |
| K800222 | MODEL 412 ELECTROFLUIDIC MANOMETER | Med-Tek Corp. | Feb 29, 1980 | SESE |
| K800179 | INFRASONDE AUTO/INFLATOR ELEC. VIBRATOR | Sphygmetrics, Inc. | Feb 11, 1980 | SESE |
Top Applicants
- Cas Medical Systems, Inc. — 1 clearance
- Med-Tek Corp. — 1 clearance
- Millar Instruments, Inc. — 1 clearance
- Newmed Corp. — 1 clearance
- Sphygmetrics, Inc. — 1 clearance
