510(k) DEN250033
DEN250033 is an FDA 510(k) premarket notification submitted by Hjarta Care, LLC for the device "XplantR Explant Tool". The FDA issued a decision of De Novo Granted on Apr 17, 2026. The device falls under product code SHR (Device For Open Surgical Explant Of Endovascular Prostheses), a Class II device regulated under 21 CFR 870.4520.
Clearance Details
- Decision
- DENG (De Novo Granted)
- Decision Date
- Apr 17, 2026
- Date Received
- Aug 7, 2025
- Clearance Type
- Direct
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Device For Open Surgical Explant Of Endovascular Prostheses
- Device Class
- Class II
- Regulation Number
- 870.4520
- Review Panel
- CV
- Submission Type
This device is a non-implantable mechanical surgical tool to aid in the open surgical removal of endovascular prostheses in blood vessels.