510(k) K945521

CENTERMARK(R) PICC INSERTION TRAY LANDMARK(R) MIDLINE CATHETER PREP TRAY by Menlo Care, Inc. — Product Code FOZ

K945521 is an FDA 510(k) premarket notification submitted by Menlo Care, Inc. for the device "CENTERMARK(R) PICC INSERTION TRAY LANDMARK(R) MIDLINE CATHETER PREP TRAY". The FDA issued a decision of Substantially Equivalent on April 6, 1995. The device falls under product code FOZ (Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days), a Class II device regulated under 21 CFR 880.5200. Menlo Care, Inc. has at least 10 other 510(k) clearances on record.