DXLClass II
Injector, Indicator
21 CFR 870.1660 / Cardiovascular
DXL is the FDA product code for Injector, Indicator, a class II device type, regulated under 21 CFR 870.1660. As of , FDA records hold 3 510(k) clearances under this code, the most recent dated , and no recalls.
Classification record
- Product code
- DXL
- Device name
- Injector, Indicator
- Regulation
- 21 CFR 870.1660
- 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
- 3
- Ingested recalls
- 0
Clearances, product code DXL
By decision yearShow the numbers
| Year | Clearances |
|---|---|
| 1976 | 3 |
Applicants with the most clearances
Product code DXL| Applicant | Clearances |
|---|---|
| Instrumentation Laboratory Co. | 2 |
| Unimetrics Corp. | 1 |
Companies listing this code with FDA
Companies whose registered establishments list this codeNo registered establishment in MDM’s records lists product code DXL.
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.
