Product code DXL
- Device name
- Injector, Indicator
- Medical specialty
- Cardiovascular
- Device class
- 2
- Regulation number
- 870.1660
- Review panel
- CV
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- Y
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records
| 510(k) | Device | Applicant | Decision date |
|---|
| K760500 | TUBE, HEAVY GLASS WALL INJECTION | Unimetrics Corp. | 1976-09-03 |
| K760448 | SYRINGE, CO2 DRIVEN, IL AUTOMATIC INJECT | Instrumentation Laboratory CO | 1976-08-27 |
| K760066 | TRAY, ICED INJECTABLE (26420) | Instrumentation Laboratory CO | 1976-07-21 |