FDA product code DXW: System, Phonocatheter, Intracavitary
DXW is the FDA product code for system, phonocatheter, intracavitary. It is a Class II device, regulated under 21 CFR 870.1270 and reviewed by the Cardiovascular panel. FDA has cleared 5 510(k) submissions under DXW, from 5 different applicants. The average 510(k) review took 131 days (median 30).
Classification
| Field | Value |
|---|---|
| Device name | System, Phonocatheter, Intracavitary |
| Device class | Class II |
| Regulation | 21 CFR 870.1270 |
| Review panel | CV — Cardiovascular |
| Medical specialty | Cardiovascular |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
Compare with all 510(k) review times · Search every DXW clearance
Top DXW applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Cas Medical Systems, Inc. | 1 | 1998-05-05 |
| Newmed Corp. | 1 | 1996-09-05 |
| Millar Instruments, Inc. | 1 | 1980-12-10 |
| Med-Tek Corp. | 1 | 1980-02-29 |
| Sphygmetrics, Inc. | 1 | 1980-02-11 |
Most recent DXW clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K972020 | Cas Medical Systems, Inc. | OSCILLOMATE NON-INVASIVE BLOOD PRESSURE MONITOR | 1998-05-05 | 337 |
| K955887 | Newmed Corp. | NEWMED ABP-LITE | 1996-09-05 | 252 |
| K802830 | Millar Instruments, Inc. | MILLAR MIKRO-TIP CATHETER PHONOTRANS | 1980-12-10 | 30 |
| K800222 | Med-Tek Corp. | MODEL 412 ELECTROFLUIDIC MANOMETER | 1980-02-29 | 25 |
| K800179 | Sphygmetrics, Inc. | INFRASONDE AUTO/INFLATOR ELEC. VIBRATOR | 1980-02-11 | 13 |
Recalls for DXW devices
openFDA lists no recalls for product code DXW.
Frequently asked questions
What is FDA product code DXW?
DXW is the FDA product code for system, phonocatheter, intracavitary. It is a Class II device, regulated under 21 CFR 870.1270 and reviewed by the Cardiovascular panel.
What device class is DXW?
Class II, regulation 21 CFR 870.1270. Typical premarket route: 510(k).
How long does a 510(k) take for product code DXW?
Across 5 cleared submissions the average was 131 days from receipt to decision (median 30).
Which companies have the most DXW clearances?
Cas Medical Systems, Inc. (1); Newmed Corp. (1); Millar Instruments, Inc. (1); Med-Tek Corp. (1); Sphygmetrics, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code DXW
- Run a recall and safety report across every DXW manufacturer
- Watch product code DXW for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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