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

    CEPTI-SEAL I.V. PREP KIT

    K Number: K930196 · Decision Jul 2, 1993
    View on FDA
    Classifications
    1
    FEI Numbers
    68
    Registration Numbers
    68
    Same Product Code
    29
    Applicant Total
    13
    Review Days
    169

    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
    CEPTI-SEAL I.V. PREP KIT
    K Number
    K930196
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.5200
    Medical Specialty
    General Hospital
    Decision
    Unknown
    Statement or Summary
    Statement
    Applicant
    Medi-Flex Hospital Products, Inc.
    Date Received
    January 14, 1993
    Decision Date
    July 2, 1993
    Product Code
    LRS
    Advisory Committee
    General Hospital
    Review Advisory Committee
    SU
    Third Party
    N

    Classifications

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

    Product Code Device Name
    LRS I.V. Start Kit

    Similar 510(k) Clearances

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

    AMSINO I.V. START KIT

    FDA 510(k)
    FDA Class 2 ·General Hospital

    INFUSION IV SET

    FDA 510(k)
    FDA Class 2 ·General Hospital

    IV START KIT

    FDA 510(k)
    FDA Class 2 ·General Hospital

    EMS I.V. START KIT

    FDA 510(k)
    FDA Class 2 ·General Hospital

    B. BRAUN IV START KITS

    FDA 510(k)
    FDA Class 2 ·General Hospital

    PERSONAL HEARING SYSTEM

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

    Other Clearances by Medi-Flex Hospital Products, Inc.

    K Number Device Name
    K970441 K-KLOSURE 2 INCH LENGTH/4 INCH LENGTH/8 INCH LENGTH/12 INCH LENGTH
    K962740 DERMISTICK SEPP APPLICATOR(200 CT)/(40 CT) 260640/260641
    K952201 PORT-A-CATH ACCESS KIT
    K952416 TRACHEOSTOMY CARE KIT
    K952256 PICC LINE KIT
    K952007 ADHEROL SEPP APPLICATOR
    K934790 SEPP ADHESIVE REMOVER
    K920399 COMPOUND BENZOIN TINCTURE USP FREPP
    K923516 COMPOUND BENZOIN TINCTURE USP SEPP
    K921347 CEPTI-SEAL DRESSING CHANGE KIT FOR VENOUS CATHETER
    Search all 13 clearances from Medi-Flex Hospital Products, Inc. →