510(k) K910425

LARGE VOLUME ELASTOMERIC INFUSION DEVICE ATTACH. by Baxter Healthcare Corp — Product Code FRN

K910425 is an FDA 510(k) premarket notification submitted by Baxter Healthcare Corp for the device "LARGE VOLUME ELASTOMERIC INFUSION DEVICE ATTACH.". The FDA issued a decision of Substantially Equivalent on Apr 1, 1991. The device falls under product code FRN (Pump, Infusion), a Class II device regulated under 21 CFR 880.5725. Baxter Healthcare Corp has 507 other 510(k) clearances on record.