DeviceClearance

Product code SHR— Cardiovascular

XplantR Explant Tool

Classification name
Device For Open Surgical Explant Of Endovascular Prostheses
Device class
Class 2
Regulation
21 CFR 870.4520
Advisory panel
Cardiovascular
Total cleared
1
First cleared
Most recent

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.”

— U.S. Food and Drug Administration, device classification record for product code SHR under 21 CFR 870.4520, via openFDA

Market context for product code SHR

FDA has cleared 1 device under product code SHR, all in 2026, filed by 1 applicant company. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Top applicants under product code SHR

Recent clearances under product code SHR

Data sourced from openFDA. This site is unofficial and independent of the FDA.