510(k) K063293

EDWARDS AQUALINE STERILE TUBING SET; EDWARDS AQUALINS STERILE TUBING SET; EDWARDS AQUASPIKE AND AQUASAFE by Edwards Lifesciences Services GmbH — Product Code FJK

K063293 is an FDA 510(k) premarket notification submitted by Edwards Lifesciences Services GmbH for the device "EDWARDS AQUALINE STERILE TUBING SET; EDWARDS AQUALINS STERILE TUBING SET; EDWARDS AQUASPIKE AND AQUASAFE". The FDA issued a decision of Substantially Equivalent on March 23, 2007. 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. Edwards Lifesciences Services GmbH has at least 2 other 510(k) clearances on record.