# DEN250033: XplantR Explant Tool

- Pathway: De Novo (Direct)
- Applicant: Hjarta Care, LLC
- Decided: Apr 17, 2026 after 253 days
- Product code: SHR (Device For Open Surgical Explant Of Endovascular Prostheses)
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. De Novo decisions do not claim a predicate device.

## Indications for use
The XplantR Explant Tool is indicated for use in open surgical conversion after endovascular abdominal aortic aneurysm repair to aid in the disengagement of the stent graft from the aorta. The XplantR is to be used when, at the discretion of the operating physician, the proximal end of the endovascular graft is to be removed.

Source page: https://510kreport.com/device/DEN250033
Methodology: https://510kreport.com/methodology