510(k) K001245

3T L. V. CONTROL VALVE by 3t Medical Systems, LLC — Product Code MJJ

K001245 is an FDA 510(k) premarket notification submitted by 3t Medical Systems, LLC for the device "3T L. V. CONTROL VALVE". The FDA issued a decision of Substantially Equivalent on August 15, 2001. The device falls under product code MJJ (Cpb Check Valve, Retrograde Flow, In-Line), a Class II device regulated under 21 CFR 870.4400. 3t Medical Systems, LLC has at least 4 other 510(k) clearances on record.