510(k) K962978

CCENTERMARK CATHETER INTRODUCER SHEALTH WITH PROTECTIV 2000 NEEDLE SAFETY SYSTEM by Johnson & Johnson Medical, Inc. — Product Code DYB

K962978 is an FDA 510(k) premarket notification submitted by Johnson & Johnson Medical, Inc. for the device "CCENTERMARK CATHETER INTRODUCER SHEALTH WITH PROTECTIV 2000 NEEDLE SAFETY SYSTEM". The FDA issued a decision of Substantially Equivalent on January 7, 1997. The device falls under product code DYB (Introducer, Catheter), a Class II device regulated under 21 CFR 870.1340. Johnson & Johnson Medical, Inc. has at least 10 other 510(k) clearances on record.