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

    CCENTERMARK CATHETER INTRODUCER SHEALTH WITH PROTECTIV 2000 NEEDLE SAFETY SYSTEM

    K Number: K962978 · Decision Jan 7, 1997
    View on FDA
    Classifications
    1
    FEI Numbers
    273
    Registration Numbers
    273
    Same Product Code
    701
    Applicant Total
    53
    Review Days
    160

    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
    CCENTERMARK CATHETER INTRODUCER SHEALTH WITH PROTECTIV 2000 NEEDLE SAFETY SYSTEM
    K Number
    K962978
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.1340
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Johnson & Johnson Medical, Inc.
    Date Received
    July 31, 1996
    Decision Date
    January 7, 1997
    Product Code
    DYB
    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
    DYB Introducer, Catheter

    Similar 510(k) Clearances

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

    FieldFlex Steerable Sheath

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Echo Large Bore Introducer Sheath

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Introducer Sheath Set

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Edwards eSheath+ introducer set

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Aventus Introducer Sheath

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Protaryx Transseptal Puncture Device (PTX2-001)

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

    Other Clearances by Johnson & Johnson Medical, Inc.

    K Number Device Name
    K001690 PROTECTIV SAFETY BLOOD COLLECTION NEEDLE
    K982641 ADVANCED NIBP MODULE
    K983362 NU-GEL * WOUND DRESSING
    K982597 FIBRCOL PLUS COLLAGEN WOUND DRESSING WITH ALGINATE
    K974080 CRITIKON SOFT BLOOD PRESSURE CUFF
    K980493 I.V. CATHETER SYSTEM
    K972498 OBSERVER * CENTRAL STATION
    K973699 ULTRALON POWDER FREE LATEX SURGICAL GLOVE
    K971569 DINAMAP MPS PORTABLE MONITOR
    K970182 DINAMAP COMPACT MONITOR
    Search all 53 clearances from Johnson & Johnson Medical, Inc. →