510(k) K974013

EXTENSION SET WITH MICROBORE TUBING, EXTENSION SET WITH MICROBORE TUBING AND 0.2 U FILTER, EXTENSION SET WITH MICROBORE by Sims Deltec, Inc. — Product Code FPA

K974013 is an FDA 510(k) premarket notification submitted by Sims Deltec, Inc. for the device "EXTENSION SET WITH MICROBORE TUBING, EXTENSION SET WITH MICROBORE TUBING AND 0.2 U FILTER, EXTENSION SET WITH MICROBORE". The FDA issued a decision of Substantially Equivalent on December 17, 1997. The device falls under product code FPA (Set, Administration, Intravascular), a Class II device regulated under 21 CFR 880.5440. Sims Deltec, Inc. has at least 10 other 510(k) clearances on record.