510(k) K112628

NIPRO BLOOD TUBING SET WITH TRANSDUCER PROTECTOR AND PRIMING SET by Nipro Medical Corporation — Product Code FJK

K112628 is an FDA 510(k) premarket notification submitted by Nipro Medical Corporation for the device "NIPRO BLOOD TUBING SET WITH TRANSDUCER PROTECTOR AND PRIMING SET". The FDA issued a decision of Substantially Equivalent on September 28, 2012. The device falls under product code FJK (Set, Tubing, Blood, With And Without Anti-Regurgitation Valve), a Class II device regulated under 21 CFR 876.5820. Nipro Medical Corporation has at least 10 other 510(k) clearances on record.