Skip to contentDe Novo DEN190043
- Device
- SafeBreak Vascular
- Contact
- lemuel v. clement
- De Novo number
- DEN190043
- Product code
- QOI
- Regulation
- 880.5220
- Classification name
- intravenous catheter force-activated separation device.
- Decision
- granted (DENG)
- Decision date
- 2021-05-27
- Date received
- 2019-09-18
- Classification advisory
- General Hospital
- Review advisory
- General Hospital
- Type
- Direct
Current FDA Classification#
- Product code
- QOI
- Device name
- Intravenous Catheter Force-Activated Separation Device.
- Medical specialty
- General Hospital
- Device class
- 2
- Regulation
- 880.5220
- Implant
- N
- Life sustain/support
- N