510(k) K772147

GW 35 GUIDE WIRE by Sorensen Research — Product Code FIF

K772147 is an FDA 510(k) premarket notification submitted by Sorensen Research for the device "GW 35 GUIDE WIRE". The FDA issued a decision of Substantially Equivalent on November 28, 1977. The device falls under product code FIF (Set, Dialysis, Single Needle With Uni-Directional Pump), a Class II device regulated under 21 CFR 876.5820. Sorensen Research has at least 10 other 510(k) clearances on record.