System, Phonocatheter, Intracavitary
The Intracavitary Phonocatheter System is a cardiovascular device used to detect and record sounds produced within the heart chambers and great vessels by means of a microphone mounted on or within a catheter, aiding in cardiac diagnosis. It is classified as FDA Class 2, indicating moderate risk, and requires 510(k) clearance prior to marketing. The product code is DXW and the applicable regulation is 21 CFR 870.1270, under the Cardiovascular medical specialty. This device is eligible for third-party 510(k) review.
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Basic Information
- Product Code
- DXW
- Device Class
- FDA class 2
- Regulation Number
- 870.1270
- Medical Specialty
- Cardiovascular
- Review Panel
- CV
- Submission Type
- 1
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 5 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K972020 | OSCILLOMATE NON-INVASIVE BLOOD PRESSURE MONITOR | May 05, 1998 | Substantially Equivalent | Cas Medical Systems, Inc. |
| K955887 | NEWMED ABP-LITE | Sep 05, 1996 | Substantially Equivalent | Newmed Corp. |
| K802830 | MILLAR MIKRO-TIP CATHETER PHONOTRANS | Dec 10, 1980 | Substantially Equivalent | Millar Instruments, Inc. |
| K800222 | MODEL 412 ELECTROFLUIDIC MANOMETER | Feb 29, 1980 | Substantially Equivalent | Med-Tek Corp. |
| K800179 | INFRASONDE AUTO/INFLATOR ELEC. VIBRATOR | Feb 11, 1980 | Substantially Equivalent | Sphygmetrics, Inc. |