510(k) K213666

NuCath Wedge Pressure Catheter by Pfm Medical, Inc. — Product Code DQO

K213666 is an FDA 510(k) premarket notification submitted by Pfm Medical, Inc. for the device "NuCath Wedge Pressure Catheter". The FDA issued a decision of Substantially Equivalent on October 6, 2022. The device falls under product code DQO (Catheter, Intravascular, Diagnostic), a Class II device regulated under 21 CFR 870.1200. Pfm Medical, Inc. has at least 10 other 510(k) clearances on record.