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

    CATHETER MAINTENANCE KIT

    K Number: K811247 · Decision Jun 12, 1981
    View on FDA
    Classifications
    1
    FEI Numbers
    194
    Registration Numbers
    194
    Same Product Code
    321
    Applicant Total
    16
    Review Days
    38

    Research this 510(k) in seconds

    The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Basic Information

    Device Name
    CATHETER MAINTENANCE KIT
    K Number
    K811247
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.6850
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Applicant
    Clinipad Corp.
    Date Received
    May 5, 1981
    Decision Date
    June 12, 1981
    Product Code
    FRG
    Advisory Committee
    General Hospital
    Review Advisory Committee
    HO
    Third Party
    N

    Classifications

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

    Product Code Device Name
    FRG Wrap, Sterilization

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (FRG), ordered by most recent decision date.

    Dukal Crepe Paper Sterilization Wrap

    FDA 510(k)
    FDA Class 2 ·General Hospital

    HALYARD* ONE-STEP* Sterilization Wrap; HALYARD* QUICK CHECK* Sterilization Wrap; HALYARD* SEQUENTIAL Sterilization Wrap; HALYARD* SMART-FOLD* Sterilization Wrap

    FDA 510(k)
    FDA Class 2 ·General Hospital

    Sterilization Pouch/Roll

    FDA 510(k)
    FDA Class 2 ·General Hospital

    Self-Seal Sterilization Pouch and Roll

    FDA 510(k)
    FDA Class 2 ·General Hospital

    Chex-All Sterilization Pouches and Tubes

    FDA 510(k)
    FDA Class 2 ·General Hospital

    Sterilization Pouch and Roll

    FDA 510(k)
    FDA Class 2 ·General Hospital
    View all

    Other Clearances by Clinipad Corp.

    K Number Device Name
    K931560 CARDIAC CATHETERIZATION TRAY
    K931668 PICC INSERTION TRAY
    K932071 I.V. START KIT
    K932010 V.A.D. ACCESS KIT
    K932036 LACERATION TRAY
    K932016 TRACHEOSTOMY CARE TRAY
    K862562 PUNCH BIOPSY KIT
    K862563 TRACHEOSTOMY CLEANSING SOLUTION
    K833075 WET DRESSING KIT
    K833432 CATHETER INSERTION KIT
    Search all 16 clearances from Clinipad Corp. →