BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    L-CATH CONNECTOR ASSEMBLY

    K Number: K940198 · Decision Dec 15, 1994
    View on FDA
    Classifications
    1
    FEI Numbers
    69
    Registration Numbers
    69
    Same Product Code
    7
    Applicant Total
    17
    Review Days
    336

    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
    L-CATH CONNECTOR ASSEMBLY
    K Number
    K940198
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    878.4200
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Luther Medical Products, Inc.
    Date Received
    January 13, 1994
    Decision Date
    December 15, 1994
    Product Code
    GCD
    Advisory Committee
    General, Plastic Surgery
    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
    GCD Connector, Catheter

    Similar 510(k) Clearances

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

    ACTI-FLEX LOW, MEDIUM, RESCARE I, RESCARE II.

    FDA 510(k)
    FDA Class 1 ·General, Plastic Surgery

    ANGIOMED HIGH PRESSURE CONNECTORS

    FDA 510(k)
    FDA Class 1 ·General, Plastic Surgery

    INCISION DRAIN

    FDA 510(k)
    FDA Class 1 ·General, Plastic Surgery

    Y CONNECTOR

    FDA 510(k)
    FDA Class 1 ·General, Plastic Surgery

    CATHETER CONNECTOR, ARGYLE TUBING

    FDA 510(k)
    FDA Class 1 ·General, Plastic Surgery

    CONNECTORS

    FDA 510(k)
    FDA Class 1 ·General, Plastic Surgery
    View all

    Other Clearances by Luther Medical Products, Inc.

    K Number Device Name
    K982797 BLUNT T-PEEL INTRODUCER MODEL NUMBER PE-16PICB, PE-18PICB, PE-20PICB, PE-24PICB
    K980090 ONECATH, L-CATH CATHETER SYSTEM, MODEL OC-(16-22 GA., 5CM-60CM)
    K974543 L-CATH MODIFIED SELDINGER TECHNIQUE INSERTION/CATHETER EXCHANGE KIT PE-MST24-24 GA. KIT, L-CATH MODIFIED SELDINGER
    K942103 L-CATH CATHETER SYSTEM - PORT L-CATH
    K930473 ONECATH L-CATH CATHETER SYSTEM
    K925236 L CATH(R) CATHETER SYSTEM
    K920755 L-CATH PEEL AWAY SYSTEM CATHETER
    K925979 DUAL LUMEN L-CATH CATHETER SYSTEM
    K924968 L-CATH PEEL-AWAY CATHETER SYSTEM
    K924562 CATHETER INTRODUCER
    Search all 17 clearances from Luther Medical Products, Inc. →