510(k) K915421

GUIDEWIRE INTRODUCER SET by B. Braun of America, Inc. — Product Code DYB

K915421 is an FDA 510(k) premarket notification submitted by B. Braun of America, Inc. for the device "GUIDEWIRE INTRODUCER SET". The FDA issued a decision of Substantially Equivalent on February 27, 1992. The device falls under product code DYB (Introducer, Catheter), a Class II device regulated under 21 CFR 870.1340. B. Braun of America, Inc. has at least 10 other 510(k) clearances on record.