510(k) K153461

Guide wire for Edi Catheter 6 Fr, Guide wire for Edi Catheter 8 Fr, 100 cm, Guide wire for Edi Catheter 8 Fr, 125 cm by Maquet Critical Care AB — Product Code KNT

K153461 is an FDA 510(k) premarket notification submitted by Maquet Critical Care AB for the device "Guide wire for Edi Catheter 6 Fr, Guide wire for Edi Catheter 8 Fr, 100 cm, Guide wire for Edi Catheter 8 Fr, 125 cm". The FDA issued a decision of Substantially Equivalent on December 11, 2015. 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.