Catheter, Urological (Antimicrobial) And Accessories
The Antimicrobial Urological Catheter and Accessories is a urethral or urinary catheter coated or impregnated with antimicrobial agents designed to reduce the risk of catheter-associated urinary tract infections in patients requiring bladder drainage. Classified as a Class 2 device under 21 CFR 876.5130 within the Gastroenterology and Urology specialty, it requires 510(k) premarket notification. It is subject to general and special controls and carries no implant or life-sustaining flags.
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Basic Information
- Product Code
- MJC
- Device Class
- FDA class 2
- Regulation Number
- 876.5130
- Medical Specialty
- Gastroenterology, Urology
- Review Panel
- GU
- Submission Type
- 1
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 10 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K233094 | Wellead® Latex Foley Catheter | Jun 06, 2024 | Substantially Equivalent | Well Lead Medical (Hainan) Co., Ltd. |
| K040658 | BARDEX I.C. LATEX FOLEY CATHETER | Sep 29, 2004 | Substantially Equivalent | C.R. Bard, Inc. |
| K033477 | HYDROPHILIC-ANTIBACTERIAL INTERMITTENT CATHETER, INTERMITTENT CATHETER CLOSED SYSTEM KIT | Jun 10, 2004 | Substantially Equivalent | Rochester Medical Corp. |
| K000251 | SPECTRUM SILICONE FOLEY CATHETER | Aug 30, 2000 | Substantially Equivalent | Cook Urological, Inc. |
| K001143 | RELEASE NF ANTIBACTERIAL FOLEY CATHETER, ANTIBACTERIAL PERSONAL CATHETER | Jul 07, 2000 | Substantially Equivalent | Rochester Medical Corp. |
| K993464 | BARDEX I.C. PEDIATRIC FOLEY CATHETER | Dec 10, 1999 | Substantially Equivalent | C.R. Bard, Inc. |
| K984136 | BARDEX LUBRI-SIL I.C. FOLEY CATHETER | Feb 16, 1999 | Substantially Equivalent | Bard Medical Div. |
| K983101 | BARDEX I.C 4-WAY FOLEY CATHETER MODEL 1865SIXX XX = 18,20,22,24 | Nov 03, 1998 | Substantially Equivalent | C.R. Bard, Inc. |
| K971627 | SILICONE ANTIBACTERIAL FOLEY CATHETER | Jan 13, 1998 | Substantially Equivalent | Rochester Medical Corp. |
| K910318 | BARD(R) HYDROGEL/SILVER-COATED FOLEY CATHETER | Aug 18, 1994 | Substantially Equivalent | C.R. Bard, Inc. |
FEI Numbers
This FDA classification entry is associated with 11 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 11 registration numbers. Click on an entry to view related FDA registrations.