510(k) K101199

GUIDE WIRE FOR EDI CATHETER, 8FR,125CM,5 EACH,GUIDE WIRE FOR EDI CATHETER, 8FR,125CM,5 EACH,GUIDE WIRE FOR EDI CATHETER, by Maquet Critical Care AB — Product Code KNT

K101199 is an FDA 510(k) premarket notification submitted by Maquet Critical Care AB for the device "GUIDE WIRE FOR EDI CATHETER, 8FR,125CM,5 EACH,GUIDE WIRE FOR EDI CATHETER, 8FR,125CM,5 EACH,GUIDE WIRE FOR EDI CATHETER,". The FDA issued a decision of Substantially Equivalent on August 27, 2010. The device falls under product code KNT (Tubes, Gastrointestinal (And Accessories)), a Class II device regulated under 21 CFR 876.5980. Maquet Critical Care AB has at least 10 other 510(k) clearances on record.