WASHINGTON, April 30 -- Food and Drug Administration has issued a rule called: Medical Devices; Cardiovascular Devices; Classification of the Laser-Powered Inferior Vena Cava Filter Retrieval Catheter.
The rule was published in the Federal Register on April 30 by Grace R. Graham, Deputy Commissioner for Policy, Legislation, and International Affairs.
Summary: The Food and Drug Administration (FDA) is classifying the laser-powered inferior vena cava filter retrieval catheter into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for classification of the laser-powered inferior vena cava filter retrieval catheter. We are taking this action b...