510(k) K834237

GRADUATED GUIDE WIRE BOWL 8 by Sterile Design, Inc. — Product Code DQX

K834237 is an FDA 510(k) premarket notification submitted by Sterile Design, Inc. for the device "GRADUATED GUIDE WIRE BOWL 8". The FDA issued a decision of Substantially Equivalent on February 4, 1984. The device falls under product code DQX (Wire, Guide, Catheter), a Class II device regulated under 21 CFR 870.1330. Sterile Design, Inc. has at least 9 other 510(k) clearances on record.