510(k) K213174

Salem Sump Silicone Dual Lumen Stomach Tube with ENFit Connection by Cardinalhealth — Product Code PIF

K213174 is an FDA 510(k) premarket notification submitted by Cardinalhealth for the device "Salem Sump Silicone Dual Lumen Stomach Tube with ENFit Connection". The FDA issued a decision of Substantially Equivalent on May 19, 2022. The device falls under product code PIF (Gastrointestinal Tubes With Enteral Specific Connectors), a Class II device regulated under 21 CFR 876.5980. Cardinalhealth has at least 10 other 510(k) clearances on record.