510(k) K964556

HR POLYURETHANE PICC AND MIDLINE CATHETERS by Johnson & Johnson Medical, Inc. — Product Code LJS

K964556 is an FDA 510(k) premarket notification submitted by Johnson & Johnson Medical, Inc. for the device "HR POLYURETHANE PICC AND MIDLINE CATHETERS". The FDA issued a decision of Substantially Equivalent on April 16, 1997. 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. Johnson & Johnson Medical, Inc. has at least 10 other 510(k) clearances on record.