Product code SHR

Device name

Device For Open Surgical Explant Of Endovascular Prostheses

Medical specialty

Cardiovascular

Device class

2

Regulation number

870.4520

Review panel

CV

Implant

N

Life sustaining/supporting

N

GMP exempt

N

Third party review

N

Summary malfunction reporting

Ineligible

Definition

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

Source

FDA openFDA device classification dataset