SHR — Device For Open Surgical Explant Of Endovascular Prostheses Class II

FDA Device Classification

Classification Details

Product Code
SHR
Device Class
Class II
Regulation Number
870.4520
Submission Type
Review Panel
CV
Medical Specialty
Cardiovascular
Implant
No

Definition

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

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
DEN250033hjarta careXplantR Explant ToolApril 17, 2026