FDA.reportPublic FDA data

510(k) K033477

Device
HYDROPHILIC-ANTIBACTERIAL INTERMITTENT CATHETER, INTERMITTENT CATHETER CLOSED SYSTEM KIT
Applicant
ROCHESTER MEDICAL CORP.
510(k) number
K033477
Product code
MJC  
Decision
Substantially Equivalent (SESE)
Decision date
2004-06-10
Date received
2003-11-03
Regulation
876.5130
Classification name
Catheter, Urological (antimicrobial) And Accessories
Medical specialty
Gastroenterology/Urology
Review panel
Gastroenterology/Urology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
ROB ANGLIN
Address
One Rochester Medical Dr. Stewartville MN US 55976 55976

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code MJC  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K233094Wellead® Latex Foley CatheterWell Lead Medical (Hainan) Co., Ltd.2024-06-06
K040658BARDEX I.C. LATEX FOLEY CATHETERC.R. Bard, Inc.2004-09-29
K000251SPECTRUM SILICONE FOLEY CATHETERCook Urological, Inc.2000-08-30
K001143RELEASE NF ANTIBACTERIAL FOLEY CATHETER, ANTIBACTERIAL PERSONAL CATHETERRochester Medical Corp.2000-07-07
K993464BARDEX I.C. PEDIATRIC FOLEY CATHETERC.R. Bard, Inc.1999-12-10
K984136BARDEX LUBRI-SIL I.C. FOLEY CATHETERBard Medical Div.1999-02-16
K983101BARDEX I.C 4-WAY FOLEY CATHETER MODEL 1865SIXX XX = 18,20,22,24C.R. Bard, Inc.1998-11-03
K971627SILICONE ANTIBACTERIAL FOLEY CATHETERRochester Medical Corp.1998-01-13
K910318BARD(R) HYDROGEL/SILVER-COATED FOLEY CATHETERC.R. Bard, Inc.1994-08-18

Legacy Summary#

summary

FDA Review#

Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases