FDA 510(k) Applications for Medical Device Product Code "MJC"
(Catheter, Urological (Antimicrobial) And Accessories)

FDA 510(k) Number Applicant Device Name Decision Date
K984136 BARD MEDICAL DIV. BARDEX LUBRI-SIL I.C. FOLEY CATHETER 02/16/1999
K983101 C.R. BARD, INC. BARDEX I.C 4-WAY FOLEY CATHETER MODEL 1865SIXX XX = 18,20,22,24 11/03/1998
K040658 C.R. BARD, INC. BARDEX I.C. LATEX FOLEY CATHETER 09/29/2004
K993464 C.R. BARD, INC. BARDEX I.C. PEDIATRIC FOLEY CATHETER 12/10/1999
K000251 COOK UROLOGICAL, INC. SPECTRUM SILICONE FOLEY CATHETER 08/30/2000
K033477 ROCHESTER MEDICAL CORP. HYDROPHILIC-ANTIBACTERIAL INTERMITTENT CATHETER, INTERMITTENT CATHETER CLOSED SYSTEM KIT 06/10/2004
K001143 ROCHESTER MEDICAL CORP. RELEASE NF ANTIBACTERIAL FOLEY CATHETER, ANTIBACTERIAL PERSONAL CATHETER 07/07/2000
K971627 ROCHESTER MEDICAL CORP. SILICONE ANTIBACTERIAL FOLEY CATHETER 01/13/1998


Search | Companies | Product Codes | Device Names | Contacts | Applications | Decisions | Contact