PUM — Temporary Catheter, Embolic Protection, Transcatheter Intracardiac Procedures Class II

FDA Device Classification

FDA product code PUM covers "Temporary Catheter, Embolic Protection, Transcatheter Intracardiac Procedures", a Class II medical device regulated under 21 CFR 870.1251. Submissions are reviewed by the Cardiovascular panel. At least 2 recent 510(k) clearances have been granted under this product code.