510(k) K240514

AMT Low-Profile Suprapubic Catheter & Drainage Set by Applied Medical Technology, Inc. — Product Code KOB

K240514 is an FDA 510(k) premarket notification submitted by Applied Medical Technology, Inc. for the device "AMT Low-Profile Suprapubic Catheter & Drainage Set". The FDA issued a decision of Substantially Equivalent on November 1, 2024. The device falls under product code KOB (Catheter, Suprapubic (And Accessories)), a Class II device regulated under 21 CFR 876.5090. Applied Medical Technology, Inc. has at least 10 other 510(k) clearances on record.