510(k) K961928

BIOMEDIX I.V. EXTENSION LINE W/ STOPCOCK MODEL B50-102/B51-102 by Biomedix, Inc. — Product Code FPA

K961928 is an FDA 510(k) premarket notification submitted by Biomedix, Inc. for the device "BIOMEDIX I.V. EXTENSION LINE W/ STOPCOCK MODEL B50-102/B51-102". The FDA issued a decision of Substantially Equivalent on September 16, 1996. The device falls under product code FPA (Set, Administration, Intravascular), a Class II device regulated under 21 CFR 880.5440. Biomedix, Inc. has at least 10 other 510(k) clearances on record.