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MJC — Catheter, Urological (Antimicrobial) And Accessories Class II

FDA Device Classification

Classification Details

Product Code
MJC
Device Class
Class II
Regulation Number
876.5130
Submission Type
Review Panel
GU
Medical Specialty
Gastroenterology, Urology
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K233094well lead medical (hainan) coWellead® Latex Foley CatheterJune 6, 2024
K040658c.r. bardBARDEX I.C. LATEX FOLEY CATHETERSeptember 29, 2004
K033477rochester medicalHYDROPHILIC-ANTIBACTERIAL INTERMITTENT CATHETER, INTERMITTENT CATHETER CLOSED SYJune 10, 2004
K000251cook urologicalSPECTRUM SILICONE FOLEY CATHETERAugust 30, 2000
K001143rochester medicalRELEASE NF ANTIBACTERIAL FOLEY CATHETER, ANTIBACTERIAL PERSONAL CATHETERJuly 7, 2000
K993464c.r. bardBARDEX I.C. PEDIATRIC FOLEY CATHETERDecember 10, 1999
K984136bard medical divBARDEX LUBRI-SIL I.C. FOLEY CATHETERFebruary 16, 1999
K983101c.r. bardBARDEX I.C 4-WAY FOLEY CATHETER MODEL 1865SIXX XX = 18,20,22,24November 3, 1998
K971627rochester medicalSILICONE ANTIBACTERIAL FOLEY CATHETERJanuary 13, 1998
K910318c.r. bardBARD(R) HYDROGEL/SILVER-COATED FOLEY CATHETERAugust 18, 1994