Product code MJC
- Device name
- Catheter, Urological (Antimicrobial) And Accessories
- Medical specialty
- Gastroenterology, Urology
- Device class
- 2
- Regulation number
- 876.5130
- Review panel
- GU
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- Y
- Summary malfunction reporting
- Ineligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K233094 | Wellead® Latex Foley Catheter | Well Lead Medical (Hainan) Co., Ltd. | 2024-06-06 |
| K040658 | BARDEX I.C. LATEX FOLEY CATHETER | C.R. Bard, Inc. | 2004-09-29 |
| K033477 | HYDROPHILIC-ANTIBACTERIAL INTERMITTENT CATHETER, INTERMITTENT CATHETER CLOSED SYSTEM KIT | Rochester Medical Corp. | 2004-06-10 |
| K000251 | SPECTRUM SILICONE FOLEY CATHETER | Cook Urological, Inc. | 2000-08-30 |
| K001143 | RELEASE NF ANTIBACTERIAL FOLEY CATHETER, ANTIBACTERIAL PERSONAL CATHETER | Rochester Medical Corp. | 2000-07-07 |
| K993464 | BARDEX I.C. PEDIATRIC FOLEY CATHETER | C.R. Bard, Inc. | 1999-12-10 |
| K984136 | BARDEX LUBRI-SIL I.C. FOLEY CATHETER | Bard Medical Div. | 1999-02-16 |
| K983101 | BARDEX I.C 4-WAY FOLEY CATHETER MODEL 1865SIXX XX = 18,20,22,24 | C.R. Bard, Inc. | 1998-11-03 |
| K971627 | SILICONE ANTIBACTERIAL FOLEY CATHETER | Rochester Medical Corp. | 1998-01-13 |
| K910318 | BARD(R) HYDROGEL/SILVER-COATED FOLEY CATHETER | C.R. Bard, Inc. | 1994-08-18 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 00801741000263 | Bardex® I.C. Complete Care® Foley Tray | C. R. Bard, Inc. | 2016-07-23 |
| 00801741016929 | Bardex® I.C. Foley Catheter | C. R. Bard, Inc. | 2016-03-19 |
| 00801741017018 | Bardex® I.C. Councill Model Foley Catheter | C. R. Bard, Inc. | 2016-03-04 |
| 00801741017001 | Bardex® I.C. Carson Model Coude Tip Foley Catheter | C. R. Bard, Inc. | 2016-03-04 |
| 00801741016998 | Bardex® I.C. Carson Model Coude Tip Foley Catheter | C. R. Bard, Inc. | 2016-03-04 |
| 00801741016981 | Bardex® I.C. Carson Model Coude Tip Foley Catheter | C. R. Bard, Inc. | 2016-03-04 |
| 00801741016974 | Bardex® I.C. Carson Model Coude Tip Foley Catheter | C. R. Bard, Inc. | 2016-03-04 |
| 00801741016967 | Bardex® I.C. Carson Model Coude Tip Foley Catheter | C. R. Bard, Inc. | 2016-03-04 |
| 00801741016950 | Bardex® I.C. Carson Model Coude Tip Foley Catheter | C. R. Bard, Inc. | 2016-03-04 |
| 00801741016943 | Bardex® I.C. Carson Model Coude Tip Foley Catheter | C. R. Bard, Inc. | 2016-03-04 |
| 00801741016875 | Bardex® I.C. Foley Catheter | C. R. Bard, Inc. | 2016-03-01 |
| 00801741016936 | Bardex® I.C. Foley Catheter | C. R. Bard, Inc. | 2016-03-01 |
| 00801741016912 | Bardex® I.C. Foley Catheter | C. R. Bard, Inc. | 2016-03-01 |
| 00801741016905 | Bardex® I.C. Foley Catheter | C. R. Bard, Inc. | 2016-03-01 |
| 00801741016899 | Bardex® I.C. Foley Catheter | C. R. Bard, Inc. | 2016-03-01 |
| 00801741016882 | Bardex® I.C. Foley Catheter | C. R. Bard, Inc. | 2016-03-01 |
| 00801741016868 | Bardex® I.C. Foley Catheter | C. R. Bard, Inc. | 2016-03-01 |
| 00801741016851 | Bardex® I.C. Foley Catheter | C. R. Bard, Inc. | 2016-03-01 |
| 00801741016844 | Bardex® I.C. Foley Catheter | C. R. Bard, Inc. | 2016-03-01 |
| 00801741016837 | Bardex® I.C. Foley Catheter | C. R. Bard, Inc. | 2016-03-01 |
| 00801741016820 | Bardex® I.C. Foley Catheter | C. R. Bard, Inc. | 2016-03-01 |
| 00801741016813 | Bardex® I.C. Foley Catheter | C. R. Bard, Inc. | 2016-03-01 |
| 00801741016806 | Bardex® I.C. Foley Catheter | C. R. Bard, Inc. | 2016-03-01 |
| 00801741016790 | Bardex® I.C. Foley Catheter | C. R. Bard, Inc. | 2016-03-01 |
| 00801741016783 | Bardex® I.C. Foley Catheter | C. R. Bard, Inc. | 2016-03-01 |
| 00801741016776 | Bardex® I.C. Foley Catheter | C. R. Bard, Inc. | 2016-03-01 |
| 00801741016769 | Bardex® I.C. Foley Catheter | C. R. Bard, Inc. | 2016-03-01 |
| 00801741016752 | Bardex® I.C. Foley Catheter | C. R. Bard, Inc. | 2016-03-01 |
| 00801741016745 | Bardex® I.C. Foley Catheter | C. R. Bard, Inc. | 2016-03-01 |
| 00801741016738 | Bardex® I.C. Foley Catheter | C. R. Bard, Inc. | 2016-03-01 |