DXWClass II
System, Phonocatheter, Intracavitary
21 CFR 870.1270 / Cardiovascular
DXW is the FDA product code for System, Phonocatheter, Intracavitary, a class II device type, regulated under 21 CFR 870.1270. As of , FDA records hold 5 510(k) clearances under this code, the most recent dated , and no recalls.
Classification record
- Product code
- DXW
- Device name
- System, Phonocatheter, Intracavitary
- Regulation
- 21 CFR 870.1270
- Device class
- Class II
- Review panel
- Cardiovascular
- Submission type
- 510(k)
- Implant
- No
- Life sustaining or supporting
- No
- GMP exempt
- No
- Third party review eligible
- Yes
- Ingested clearances
- 5
- Ingested recalls
- 0
Clearances, product code DXW
By decision yearShow the numbers
| Year | Clearances |
|---|---|
| 1980 | 3 |
| 1996 | 1 |
| 1998 | 1 |
Applicants with the most clearances
Product code DXW| Applicant | Clearances |
|---|---|
| Cas Medical Systems, Inc. | 1 |
| Med-Tek Corp. | 1 |
| Millar LLC. | 1 |
| Newmed Inc | 1 |
| Sphygmetrics, Inc. | 1 |
Companies listing this code with FDA
Companies whose registered establishments list this codeNo registered establishment in MDM’s records lists product code DXW.
FIRST ARTICLE / WEEKLY
What cleared, what was recalled, and what changed in the standards. One edition a week for the people who make medical devices.