DXW
5 FDA 510(k) clearances · Product code
30 daysmedian time to decision
337 days90th percentile
5clearances measured
FDA profile
- Official device name
- System, Phonocatheter, Intracavitary
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.1270
- Medical specialty
- Cardiovascular
- Flags
- Third-party review eligible
- Adverse events (MAUDE)
- 2003: 1
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| OSCILLOMATE NON-INVASIVE BLOOD PRESSURE MONITOR (K972020) | Cas Medical Systems, Inc. | 1998-05-05 |
| NEWMED ABP-LITE (K955887) | Newmed Corp. | 1996-09-05 |
| MILLAR MIKRO-TIP CATHETER PHONOTRANS (K802830) | Millar Instruments, Inc. | 1980-12-10 |
| MODEL 412 ELECTROFLUIDIC MANOMETER (K800222) | Med-Tek Corp. | 1980-02-29 |
| INFRASONDE AUTO/INFLATOR ELEC. VIBRATOR (K800179) | Sphygmetrics, Inc. | 1980-02-11 |
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Every clearance here is in the API, with alerts when new ones post.