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

    CARDIAC CATHETERIZATION PACK

    K Number: K850337 · Decision Feb 25, 1985
    View on FDA
    Classifications
    1
    FEI Numbers
    100
    Registration Numbers
    100
    Same Product Code
    103
    Applicant Total
    7
    Review Days
    28

    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
    CARDIAC CATHETERIZATION PACK
    K Number
    K850337
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.1310
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Applicant
    Marwood Medical, Inc.
    Date Received
    January 28, 1985
    Decision Date
    February 25, 1985
    Product Code
    DRE
    Advisory Committee
    Cardiovascular
    Review Advisory Committee
    CV
    Third Party
    N

    Classifications

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

    Product Code Device Name
    DRE Dilator, Vessel, For Percutaneous Catheterization

    Similar 510(k) Clearances

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

    ProtekDilate Vascular Access Kit

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    VersaCross Connect™ Transseptal Dilator

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Micro Ace Gold Advanced Micro Access System

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    VersaCross Connect™ Transseptal Dilator

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    VersaCross Connect™ Transseptal Dilator

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Micro Ace™ Advanced Micro Access System

    FDA 510(k)
    FDA Class 2 ·Cardiovascular
    View all

    Other Clearances by Marwood Medical, Inc.

    K Number Device Name
    K850340 EYE PROCEDURE PACK
    K850338 EMERGENCY ROOM PACK
    K850339 SPECIAL PROCEDURES PACK
    K850341 CARDIOVASCULAR SET UP
    K840620 TPN/CVP DRESSING CHANGE KIT
    K840619 I.V. START KIT