FDA Product Code
FDA Product Code MJC — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Gastroenterology, Urology
- 21 CFR Citation
- 876.5130
510(k) Clearances — 10 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K233094 | Wellead® Latex Foley Catheter | Well Lead Medical (Hainan) Co., Ltd. | 2024-06-06 | Traditional | PDF ↗ |
| K040658 | BARDEX I.C. LATEX FOLEY CATHETER | C.R. Bard, Inc. | 2004-09-29 | Traditional | PDF ↗ |
| K033477 | HYDROPHILIC-ANTIBACTERIAL INTERMITTENT CATHETER, INTERMITTENT CATHETER CLOSED SYSTEM KIT | Rochester Medical Corp. | 2004-06-10 | Traditional | PDF ↗ |
| K000251 | SPECTRUM SILICONE FOLEY CATHETER | Cook Urological, Inc. | 2000-08-30 | Traditional | PDF ↗ |
| K001143 | RELEASE NF ANTIBACTERIAL FOLEY CATHETER, ANTIBACTERIAL PERSONAL CATHETER | Rochester Medical Corp. | 2000-07-07 | Traditional | PDF ↗ |
| K993464 | BARDEX I.C. PEDIATRIC FOLEY CATHETER | C.R. Bard, Inc. | 1999-12-10 | Abbreviated | PDF ↗ |
| K984136 | BARDEX LUBRI-SIL I.C. FOLEY CATHETER | Bard Medical Div. | 1999-02-16 | Traditional | PDF ↗ |
| K983101 | BARDEX I.C 4-WAY FOLEY CATHETER MODEL 1865SIXX XX = 18,20,22,24 | C.R. Bard, Inc. | 1998-11-03 | Abbreviated | PDF ↗ |
| K971627 | SILICONE ANTIBACTERIAL FOLEY CATHETER | Rochester Medical Corp. | 1998-01-13 | Traditional | PDF ↗ |
| K910318 | BARD(R) HYDROGEL/SILVER-COATED FOLEY CATHETER | C.R. Bard, Inc. | 1994-08-18 | Traditional | PDF ↗ |
Product code MJC · Class II · Gastroenterology, Urology. Data: openFDA.