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

    STANDARD FOLEY SYSTEM PAK

    K Number: K951443 · Decision Jun 15, 1995
    View on FDA
    Classifications
    1
    FEI Numbers
    56
    Registration Numbers
    56
    Same Product Code
    9
    Applicant Total
    44
    Review Days
    78

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    Basic Information

    Device Name
    STANDARD FOLEY SYSTEM PAK
    K Number
    K951443
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.5250
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Trinity Laboratories, Inc.
    Date Received
    March 29, 1995
    Decision Date
    June 15, 1995
    Product Code
    FCN
    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
    FCN Urinary Drainage Collection Kit, For Indwelling Catheter

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    Other Clearances by Trinity Laboratories, Inc.

    K Number Device Name
    K981441 HEART CATH TRAY, STERILE, DISPOSABLE
    K974238 DENTAL TRAY, STERILE, DISPOSABLE
    K974286 CIRCUMCISION TRAY, CAT. NO. 70340
    K972160 CRP-LEX SYSTEM: C-REACTIVE PROTEIN ANTIGEN DETECTION IN SERUM: SLIDE AGGLUTNATION LATEX TEST
    K970722 EYE TRAY
    K965201 O.R. SCRUB PREP TRAY, STERILE, DISPOSABLE
    K964921 BASIC BIOPSY TRAY. DISPOSABLE, STERILE
    K953929 MID-STREAM COLLECTION SET-STERILE
    K952058 STERILE V.A.D. (VASCULAR ACCESS DEVICES) ACCESS KIT, DISPOSABLE
    K953070 WOUNDFOAM 4 X 4
    Search all 44 clearances from Trinity Laboratories, Inc. →