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

    PEDIATRIC EUROPHYLIC FOLEY CATHETER

    K Number: K954752 · Decision Oct 30, 1995
    View on FDA
    Classifications
    1
    FEI Numbers
    119
    Registration Numbers
    119
    Same Product Code
    127
    Applicant Total
    21
    Review Days
    14

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    Basic Information

    Device Name
    PEDIATRIC EUROPHYLIC FOLEY CATHETER
    K Number
    K954752
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.5130
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Regulatory & Marketing Services, Inc.
    Date Received
    October 16, 1995
    Decision Date
    October 30, 1995
    Product Code
    EZL
    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
    EZL Catheter, Retention Type, Balloon

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    Other Clearances by Regulatory & Marketing Services, Inc.

    K Number Device Name
    K944673 MRI'S ALL SILICONE FOLEY CATHETER TEMPERATURE PROBE
    K941342 PAIN DOC
    K941543 DIAL MEDICAL KIT
    K944378 ORION'S URETHRAL CATHETERIZATION KIT WITH CATHETER AND BAG
    K944384 ORION'S URETHRAL CATHETERIZATION KIT WITHOUT BAG
    K944379 ORION'S FOLEY CATHETERIZATION KIT WITH CATHETER AND BAG
    K945874 EUROMEDICAL POLY TRACHEOTOMY TUBE
    K944383 ORION RED URETHRAL CATHETER
    K944382 ORION ALL SILICONE FOLEY CATHETER
    K944377 ORION'S URINARY DRAINAGE SET
    Search all 21 clearances from Regulatory & Marketing Services, Inc. →