510(k) K914792

PN 62290 0.22 MICRON MICRO INFUS I.V. EXTEN SET by Filtertek, Inc. — Product Code FPA

K914792 is an FDA 510(k) premarket notification submitted by Filtertek, Inc. for the device "PN 62290 0.22 MICRON MICRO INFUS I.V. EXTEN SET". The FDA issued a decision of Substantially Equivalent on January 15, 1992. The device falls under product code FPA (Set, Administration, Intravascular), a Class II device regulated under 21 CFR 880.5440. Filtertek, Inc. has at least 9 other 510(k) clearances on record.