Browse hierarchy: [Cardiovascular (CV)](/submissions/CV) → [Subpart B — Cardiovascular Diagnostic Devices](/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices) → [21 CFR 870.1270](/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/870.1270) → DXW — System, Phonocatheter, Intracavitary

# DXW · System, Phonocatheter, Intracavitary

_Cardiovascular · 21 CFR 870.1270 · Class 2_

**Canonical URL:** https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DXW

## Overview

- **Product Code:** DXW
- **Device Name:** System, Phonocatheter, Intracavitary
- **Regulation:** [21 CFR 870.1270](/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/870.1270)
- **Device Class:** 2
- **Review Panel:** [Cardiovascular](/submissions/CV)
- **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](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DXW/K972020.md) | OSCILLOMATE NON-INVASIVE BLOOD PRESSURE MONITOR | Cas Medical Systems, Inc. | May 5, 1998 | SESE |
| [K955887](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DXW/K955887.md) | NEWMED ABP-LITE | Newmed Corp. | Sep 5, 1996 | SESE |
| [K802830](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DXW/K802830.md) | MILLAR MIKRO-TIP CATHETER PHONOTRANS | Millar Instruments, Inc. | Dec 10, 1980 | SESE |
| [K800222](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DXW/K800222.md) | MODEL 412 ELECTROFLUIDIC MANOMETER | Med-Tek Corp. | Feb 29, 1980 | SESE |
| [K800179](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DXW/K800179.md) | 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

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**Source:** [https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DXW](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DXW)

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