510(k) K192577

Actreen Hi-Lite Intermittent Urinary Catheters by B.Braun Medical, Inc. — Product Code GBM

K192577 is an FDA 510(k) premarket notification submitted by B.Braun Medical, Inc. for the device "Actreen Hi-Lite Intermittent Urinary Catheters". The FDA issued a decision of Substantially Equivalent on May 7, 2020. The device falls under product code GBM (Catheter, Urethral), a Class II device regulated under 21 CFR 876.5130. B.Braun Medical, Inc. has at least 10 other 510(k) clearances on record.