EXTENSION SET WITH 0.2U FILTER AND ANTI-SIPHON VALVE CADD ADMINISTRATION SET WITH 0.2U FILTER AND ANTI-SIPHON VALVE

About This 510(k) Submission

K980583 is an FDA 510(k) clearance for the EXTENSION SET WITH 0.2U FILTER AND ANTI-SIPHON VALVE CADD ADMINISTRATION SET WITH 0.2U FILTER AND ANTI-SIPHON VALVE, a Set, Administration, Intravascular (Class II — Special Controls, product code FPA), submitted by Sims Deltec, Inc. (St. Paul, US). The FDA issued a Cleared decision on April 27, 1998, 69 days after receiving the submission on February 17, 1998. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5440.