SHR

Device For Open Surgical Explant Of Endovascular Prostheses

Product code
SHR
Device name
Device For Open Surgical Explant Of Endovascular Prostheses
Device class
Class 2
21 CFR
21 CFR 870.4520
Medical specialty
Cardiovascular
Marketing pathway
510(K)
510(k) clearances (last 3 years)
1
Summaries archived here
0 (direct download)
510(k) clearances (all years, FDA)
1 (all years; only the last 3 years are listed here)

FDA classification definition

This device is a non-implantable mechanical surgical tool to aid in the open surgical removal of endovascular prostheses in blood vessels.

Definition text from the FDA device classification database (U.S. federal government work, public domain).

510(k) clearances, last 3 years (1)

Last three years. Most recent: 2026-04-17.

NumberDecision dateApplicantDevice nameSummary
DEN2500332026-04-17Hjarta Care, LLCXplantR Explant Tool
Official FDA classification page: SHR
Classification and pathway per current FDA publications. Data from openFDA (CC0).