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510(k) Data Aggregation

    K Number
    K120130
    Device Name
    FALLER TROCAR
    Manufacturer
    MEDIGROUP, INC.
    Date Cleared
    2012-05-21

    (125 days)

    Product Code
    FJS, CLA
    Regulation Number
    876.5630
    Why did this record match?
    Applicant Name (Manufacturer) :

    MEDIGROUP, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Faller Trocar is used to create an ante-grade subcutaneous tunnel for a peritoneal dialysis catheter from the initial implantation site to the preferred exit-site. It separates the tissue as it leads the catheter through to the skin exit-site.
    Device Description
    The Faller Trocar is a surgical tool, made of either stainless steel or approved plastic, with a barbed section on one end and a sharp tip on the other end. The device is curved so that the physician using it can follow a tunnel path to lead the catheter from the initial catheter implantation site to the exit-site in an ante-grade manner.
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    K Number
    K071167
    Device Name
    FLEX-NECK EXXTENDED PERITONEAL DIALYSIS CATHETER AND ACCESSORIES, MODEL CF-5560
    Manufacturer
    MEDIGROUP, INC.
    Date Cleared
    2007-08-31

    (127 days)

    Product Code
    FJS
    Regulation Number
    876.5630
    Why did this record match?
    Applicant Name (Manufacturer) :

    MEDIGROUP, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    If a patient is a suitable adult candidate for peritoneal dialysis (PD) therapy, the Flex-Neck® ExxTended ™ peritoneal dialysis catheter can be implanted either surgically, laparoscopically, or peritoneoscopically for acute or chronic peritoneal dialysis. Stencils sold with the device, and marketed separately, will be used to assist the physician to locate the optimum primary implantation site and the optimum catheter exit site for the Flex-Neck® ExxTended™ Catheter.
    Device Description
    This device consists of a two-part peritoneal dialysis catheter and accessories. The catheter is made of long-term, implantable grade silicone tubing with a radiopaque strip, and two cuffs made of polvester felt. The coiled lower catheter section (with one rectus cuff) connects to an arcuate upper catheter section (with one exit cuff) via a tube-to-tube titanium connector (included), secured with a nonabsorbable nylon suture (not included). Also included in the catheter package is a set of stencils (right and left) to assist the physician to locate the optimum primary implantation site and the optimum catheter exit site below the sternum. (Note: In addition to being packaged with each catheter, this stencil set will be sold sterile, packaged by itself, so the physician or other qualified personnel can use it in a clinical setting prior to the implantation.) Also included in the packaging will be a surgical grade marking pen, a tape measure, a plastic catheter connector and cap, a packet of water-soluble lubricating gel, and an ExxTended™ tunneling tool.
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    K Number
    K070730
    Device Name
    FLEX-NECK ARC CATHETER
    Manufacturer
    MEDIGROUP, INC.
    Date Cleared
    2007-07-03

    (110 days)

    Product Code
    FJS
    Regulation Number
    876.5630
    Why did this record match?
    Applicant Name (Manufacturer) :

    MEDIGROUP, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    If a patient is a suitable candidate for peritoneal dialysis (PD) therapy, the Flex-Neck® ARC ™ peritoneal dialysis catheter can be implanted either surgically, laparoscopically, or peritoneoscopically for acute or chronic peritoneal dialysis.
    Device Description
    This device consists of a peritoneal dialysis catheter and accessories. The catheter is made of long-term, implantable grade silicone tubing with a radiopaque strip, and one or two cuffs made of polyester felt. The coiled catheter has a permanent bend and is available in three adult variations, three pediatric/adolescent variations, and two infant variations. Included in the catheter package is a set of stencils (right and left) to help determine which configuration of catheter to implant and to assist the physician to locate the optimum primary and secondary incision sites. (Note: In addition to being packaged with each catheter, this stencil set will be sold sterile, packaged by itself, so the physician or other qualified personnel can use it in a clinical setting prior to the implantation.) Also packaged with the catheter will be a surgical grade marking pen, a plastic catheter connector and cap, and a packet of water-soluble lubricating gel.
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    K Number
    K060897
    Device Name
    EMBEDDING TOOL, MODEL TE-1000
    Manufacturer
    MEDIGROUP, INC.
    Date Cleared
    2006-07-18

    (106 days)

    Product Code
    FJS
    Regulation Number
    876.5630
    Why did this record match?
    Applicant Name (Manufacturer) :

    MEDIGROUP, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    This device can be used to embed most known brands and styles of PD catheters when the nephrologist determines this action is in the best interest of the patient, however, only immediately after successful catheter implantation. The Embedding™ Tool is indicated for embedding the external portion of most PD catheters subcutaneously in anticipation of future retrieval of that part of the catheter, provided that: - The embedding procedure is done immediately following PD . catheter implantation. - Catheter patency has been completely established. . - The normally external part of the PD catheter can be embedded. . - The patient is a candidate for delayed onset of PD treatment. . - The patient is a candidate for PD. .
    Device Description
    The Embedding™ Tool consists of a gently curved handle portion made of rigid PVC with a detachable titanium tip and a separate titanium cap.
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    K Number
    K031351
    Device Name
    FLEX-NECK PD CATHETER, INFANT
    Manufacturer
    MEDIGROUP, INC.
    Date Cleared
    2003-09-17

    (141 days)

    Product Code
    FJS
    Regulation Number
    876.5630
    Why did this record match?
    Applicant Name (Manufacturer) :

    MEDIGROUP, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    If the patient is a suitable candidate for peritoneal dialysis (PD) therapy and is too small for the current Flex-Neck™ catheters, the Flex-Neck™ Catheter, Infant, can be implanted either surgically, peritoneoscopically or percutaneously. The only contraindication to implantation of the Flex-Neck™ PD Catheter, Infant, is if the patient is not a candidate for peritoneal dialysis.
    Device Description
    This device consists of the following components: a. 1-Flex-Neck™ Catheter, Infant, made of long-term, implantable grade silicone tubing with radiopaque strip and 1 or 2 polyester cuffs. All components are made of the same materials as the Flex-Neck™ Catheter, Adult and Pediatric. The Infant catheter also has 4 rows of side holes punched into the tubing at the distal end to facilitate inflow and outflow of dialysate. b. 1-Right hand and 1-left hand tunnel marking stencils to mark and guide and thereby assist the implanting doctor to make a sound subcutaneous tunnel for the catheter. c. 1-Surgical grade marking pen d. 1-Catheter connector, plastic e. 1-Catheter cap, plastic f. 1-Tube (20 cc) of water-soluble lubricating gel
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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?
    Applicant Name (Manufacturer) :

    MEDIGROUP, INC.

    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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