DEN250033
- 510(k) number
- DEN250033
- Device name
- XplantR Explant Tool
- Applicant
- Hjarta Care, LLC WI · US
- Product code
- SHR — Device For Open Surgical Explant Of Endovascular Pro
- Decision date
- 2026-04-17
- Date received
- 2025-08-07
- Decision
- Unknown
- Clearance type
- Direct
- Advisory committee
- Cardiovascular
Official FDA record: DEN250033
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.