21 CFR 870.4520 — Device For Open Surgical Explant Of Endovascular Prostheses

Cardiovascular (CV) · Part 870 Subpart E—Cardiovascular Surgical Devices · § 870.4520

Identification

The XplantR Explant Tool is a non-implantable mechanical surgical tool 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. It is intended for use when, at the discretion of the operating physician, the proximal end of the endovascular graft is to be removed.

Classification Rationale

FDA concludes that this device should be classified into Class II. FDA has determined that, for the previously stated indications for use, the XplantR can be classified in class II with the establishment of special controls for class II. FDA believes that class II (special) controls provide reasonable assurance of the safety and effectiveness of the device type.

Product Codes