510(k) K083451

PORTEX EPIDURAL FILTER, MODEL 100/386/010, VARIOUS STANDARD AND CUSTOM TRAYS by Smiths Medical Asd, Inc. — Product Code BSN

K083451 is an FDA 510(k) premarket notification submitted by Smiths Medical Asd, Inc. for the device "PORTEX EPIDURAL FILTER, MODEL 100/386/010, VARIOUS STANDARD AND CUSTOM TRAYS". The FDA issued a decision of Substantially Equivalent on March 4, 2009. The device falls under product code BSN (Filter, Conduction, Anesthetic), a Class II device regulated under 21 CFR 868.5130. Smiths Medical Asd, Inc. has at least 10 other 510(k) clearances on record.