510(k) K050542

MARIAN INFANT FEEDING TUBE (GUARDIANPICC PERCUTANEOUS CENTRAL VENOUS CATHETER by Marian Medical, Inc. — Product Code LJS

K050542 is an FDA 510(k) premarket notification submitted by Marian Medical, Inc. for the device "MARIAN INFANT FEEDING TUBE (GUARDIANPICC PERCUTANEOUS CENTRAL VENOUS CATHETER". The FDA issued a decision of Substantially Equivalent on July 26, 2005. The device falls under product code LJS (Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days), a Class II device regulated under 21 CFR 880.5970. Marian Medical, Inc. has at least 3 other 510(k) clearances on record.