Skip to contentDe Novo DEN250033
- Device
- XplantR Explant Tool
- Contact
- brian thorson
- De Novo number
- DEN250033
- Product code
- SHR
- Regulation
- 870.4520
- Classification name
- device for open surgical explant of endovascular prostheses
- Decision
- granted (DENG)
- Decision date
- 2026-04-17
- Date received
- 2025-08-07
- Classification advisory
- Cardiovascular
- Review advisory
- Cardiovascular
- Type
- Direct
Current FDA Classification#
- Product code
- SHR
- Device name
- Device For Open Surgical Explant Of Endovascular Prostheses
- Medical specialty
- Cardiovascular
- Device class
- 2
- Regulation
- 870.4520
- Implant
- N
- Life sustain/support
- N