510(k) K980583

EXTENSION SET WITH 0.2U FILTER AND ANTI-SIPHON VALVE CADD ADMINISTRATION SET WITH 0.2U FILTER AND ANTI-SIPHON VALVE by Sims Deltec, Inc. — Product Code FPA

K980583 is an FDA 510(k) premarket notification submitted by Sims Deltec, Inc. for the device "EXTENSION SET WITH 0.2U FILTER AND ANTI-SIPHON VALVE CADD ADMINISTRATION SET WITH 0.2U FILTER AND ANTI-SIPHON VALVE". The FDA issued a decision of Substantially Equivalent on April 27, 1998. 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.