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510(k) Data Aggregation

    K Number
    K964514
    Device Name
    CORPAK MEDSYSTEMS CRUZ CATHETER FOR PERITONEAL DIALYSIS
    Manufacturer
    CORPAK, INC.
    Date Cleared
    1998-06-26

    (605 days)

    Product Code
    FKO
    Regulation Number
    876.5630
    Why did this record match?
    Product Code :

    FKO

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The indicated use for the Cruz Catheter is for patients requiring a catheter for long term peritoneal dialysis.
    Device Description
    Cruz™ Catheter
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    K Number
    K974570
    Device Name
    PERITONEAL DIALYSIS CATHETER CONNECTOR
    Manufacturer
    MEDIGROUP, INC.
    Date Cleared
    1998-02-27

    (81 days)

    Product Code
    FKO
    Regulation Number
    876.5630
    Why did this record match?
    Product Code :

    FKO

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Peritoneal dialysis connectors are used to connect the peritoneal dialysis catheter to the dialysate line.
    Device Description
    Peritoneal dialysis connectors are used to connect the peritoneal dialysis catherer to the dialysate line. Medigroup intends to market titanium connectors for use with their large diameter, low duromoter (Flex Neck™) cathere only. Those connectors have the same intended use, general configuration, and materials as titanium connectors marketed by Accurate Surgical Instruments.
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