510(k) K913498

MX927 BLOOD TRANSFER DEVICE by Medex, Inc. — Product Code FMI

K913498 is an FDA 510(k) premarket notification submitted by Medex, Inc. for the device "MX927 BLOOD TRANSFER DEVICE". The FDA issued a decision of Substantially Equivalent on November 27, 1991. The device falls under product code FMI (Needle, Hypodermic, Single Lumen), a Class II device regulated under 21 CFR 880.5570. Medex, Inc. has at least 10 other 510(k) clearances on record.