510(k) K920828

SAFE-PICC PERIPHERALLY INSERTED CENTRAL VENOUS CAT by Menlo Care, Inc. — Product Code FOZ

K920828 is an FDA 510(k) premarket notification submitted by Menlo Care, Inc. for the device "SAFE-PICC PERIPHERALLY INSERTED CENTRAL VENOUS CAT". The FDA issued a decision of Substantially Equivalent (kit, denovo) on August 14, 1992. 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.