BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    SILICONE ANTIBACTERIAL FOLEY CATHETER

    K Number: K971627 · Decision Jan 13, 1998
    View on FDA
    Classifications
    1
    FEI Numbers
    11
    Registration Numbers
    11
    Same Product Code
    9
    Applicant Total
    13
    Review Days
    256

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    Basic Information

    Device Name
    SILICONE ANTIBACTERIAL FOLEY CATHETER
    K Number
    K971627
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.5130
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Rochester Medical Corp.
    Date Received
    May 2, 1997
    Decision Date
    January 13, 1998
    Product Code
    MJC
    Advisory Committee
    Gastroenterology, Urology
    Review Advisory Committee
    GU
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    MJC Catheter, Urological (Antimicrobial) And Accessories

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    Other Clearances by Rochester Medical Corp.

    K Number Device Name
    K122785 HYDROSIL; MAGIC; PERSONAL CATHETER
    K033477 HYDROPHILIC-ANTIBACTERIAL INTERMITTENT CATHETER, INTERMITTENT CATHETER CLOSED SYSTEM KIT
    K001143 RELEASE NF ANTIBACTERIAL FOLEY CATHETER, ANTIBACTERIAL PERSONAL CATHETER
    K000723 HYDROPHILIC SILICONE FOLEY CATHETER AND PERSONAL CATHETER (HYDROPHILIC AND NON-HYDROPHILIC)
    K981612 ALL SILICONE FOLEY CATHETER, TWO-WAY FOLEY CATHETER, THREE-WAY FOLEY CATHETER, TWO-WAY RADIOPAQUE FOLEY CATHETER
    K970704 PERSONAL CATHETER
    K952082 ROCHESTER MEDICAL CORPORATION SILICONE MALE EXTERNAL CATHETER
    K941692 FEMALE LENGTH ALL SILICONE UROLOGICAL CATHETER
    K943851 ALL SILICONE INTERMITTENT CATHETER
    K923136 MALE EXTERNAL CATHETER
    Search all 13 clearances from Rochester Medical Corp. →