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 |
| K233094 | Well Lead Medical (Hainan) Co., Ltd. | Wellead« Latex Foley Catheter | 06/06/2024 |
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