510(k) K942349

MICROBORE EXTENSION SET by Excelsior Medical Corp. — Product Code FPA

K942349 is an FDA 510(k) premarket notification submitted by Excelsior Medical Corp. for the device "MICROBORE EXTENSION SET". The FDA issued a decision of Substantially Equivalent on February 8, 1995. The device falls under product code FPA (Set, Administration, Intravascular), a Class II device regulated under 21 CFR 880.5440. Excelsior Medical Corp. has at least 8 other 510(k) clearances on record.