510(k) K791026

4F STERILE BALLOON-LESS, CATHETER 913-28 by Waters Assoc., Inc. — Product Code KRB

K791026 is an FDA 510(k) premarket notification submitted by Waters Assoc., Inc. for the device "4F STERILE BALLOON-LESS, CATHETER 913-28". The FDA issued a decision of Substantially Equivalent on June 22, 1979. The device falls under product code KRB (Probe, Thermodilution), a Class II device regulated under 21 CFR 870.1915. Waters Assoc., Inc. has at least 10 other 510(k) clearances on record.