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510(k) DEN250033

XplantR Explant Tool by Hjarta Care, LLC — Product Code SHR

Clearance Details

Decision: DENG (De Novo Granted)
Decision Date: April 17, 2026
Date Received: August 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.