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510(k) Data Aggregation

    K Number
    K061936
    Device Name
    KENDALL ARGYLE NEONATAL/PEDIATRIC PICC, MODEL 43311
    Manufacturer
    THE KENDALL COMPANY
    Date Cleared
    2006-08-09

    (30 days)

    Product Code
    LJS
    Regulation Number
    880.5970
    Why did this record match?
    Applicant Name (Manufacturer) :

    THE KENDALL COMPANY

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The proposed PICC catheter is designed for cases in which venous catheterization or long term I.V. administration is necessary in the neonate or pediatric patient. Placement is routinely achieved by a peripheral or poundine patient theter may be used to administer fluids simultaneously for hydration and parenteral nutrition, as well as other commonly used intravenous medications. The catheter is designed for cases in which venous catheterization or long term I.V. administration is necessary. Placement is routinely achieved from a peripheral venous site, but the catheter may be placed via subclavian cutdown as well. The catheter may be used to administer fluids for hydration and parenteral nutrition, as well other commonly used intravenous medications.
    Device Description
    The Argyle 1.9 Fr Neonatal/Pediatric Peripherally Inserted Central Catheter PICC) is a dual lumen polyurethane tube that bifurcates into two 5.0 Fr polyurethane tubes (pigtails), the proximal ends of the tubes ending in insert molded hubs. One pigtail is longer than the other. The primary longer lumen will be clear. The shorter secondary lumen will be tinted a lavender color to distinguish it from the primary lumen.
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    K Number
    K024010
    Device Name
    DOVER SILVER HYDROGEL COATED SILICONE FOLEY CATHETER
    Manufacturer
    THE KENDALL COMPANY DIV. OF TYCO HEALTHCARE GROUP
    Date Cleared
    2003-06-11

    (189 days)

    Product Code
    EZL
    Regulation Number
    876.5130
    Why did this record match?
    Applicant Name (Manufacturer) :

    THE KENDALL COMPANY DIV

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The proposed device is intended for use in the drainage and/or collection and/or measurement of urine. Generally drainage is accomplished by inserting the catheter through the urethra and into the bladder. However, drainage is sometimes accomplished by suprapubic or other placement of the catheter, such as a nephrostomy tract.
    Device Description
    The Kendall DOVER Silver Hydrogel Coated Silicone Foley Catheter is a sterile, single patient use, urinary drainage catheter extruded from 100% vulcanized silicone material. It is coated with a lubricious hydrophilic topcoat containing an inorganic silver releasing polymer.
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    K Number
    K030209
    Device Name
    MAHURKAR OPLUS CATHETER, MODEL 13.5 FR
    Manufacturer
    THE KENDALL COMPANY
    Date Cleared
    2003-05-13

    (112 days)

    Product Code
    MPB
    Regulation Number
    876.5540
    Why did this record match?
    Applicant Name (Manufacturer) :

    THE KENDALL COMPANY

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    MAHURKAR® QPLUS® Catheter is intended for short-term central venous access for hemodialysis, apheresis, and infusion.
    Device Description
    The MAHURKAR® QPLUS® Catheter has a 13.5Fr radiopaque polyurethane catheter shaft with two large lumens (arterial and venous) running longitudinally along the length of the catheter shaft. The catheter version with a straight shaft either has curved extensions or straight extensions. The catheter version with a pre-curved shaft has straight extensions. MAHURKAR® QPLUS® Catheter is available in kit or tray configuration which contains the sterile catheter as well as accessory items needed for insertion.
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    K Number
    K020089
    Device Name
    MAHURKAR TRIPLE LUMEN CATHETER, 12 FR
    Manufacturer
    THE KENDALL COMPANY
    Date Cleared
    2002-04-10

    (90 days)

    Product Code
    NIE
    Regulation Number
    876.5540
    Why did this record match?
    Applicant Name (Manufacturer) :

    THE KENDALL COMPANY

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    MAHURKAR® Triple Lumen Catheter is intended for short-term central venous access for hemodialysis, apheresis, and infusion.
    Device Description
    The MAHURKAR® Triple Lumen Catheter features three lumens. The catheter has a 12 Fr radiopaque polyurethane catheter shaft with two large lumens and one smaller medial lumen running longitudinally along the length of the catheter shaft. The lumina can be distinguished by the color-coded luer-lock adapters on the clear silicone rubber extensions. The two large lumens have curved extensions, and the smaller medial lumen has straight extension tubing. The catheter is available in various implantable lengths. MAHURKAR® Triple Lumen Catheter is available in singles, kit or tray configuration which contains the sterile catheter as well as accessory items needed for insertion.
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    K Number
    K011283
    Device Name
    MONOJECT PREFILL 0.9% SODIUM CHLORIDE FLUSH SYRINGE
    Manufacturer
    THE KENDALL COMPANY
    Date Cleared
    2001-10-15

    (171 days)

    Product Code
    NGT
    Regulation Number
    880.5200
    Why did this record match?
    Applicant Name (Manufacturer) :

    THE KENDALL COMPANY

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K011941
    Device Name
    EXCILON AMD ANTIMICROBIAL SPONGE MODEL #7088
    Manufacturer
    THE KENDALL COMPANY
    Date Cleared
    2001-08-22

    (62 days)

    Product Code
    FRO, EFQ
    Regulation Number
    N/A
    Why did this record match?
    Applicant Name (Manufacturer) :

    THE KENDALL COMPANY

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Primary dressing for IV sites, tracheostomy tube sites, chest tube sites, catheter and drain sites.
    Device Description
    The proposed Kendall Excilon® A.M.D. Antimicrobial Sponge is a sterile, single use wound dressing consisting of nonwoven material treated with Cosmocil®CQ. Polyhexamethylene Biguanide Hydrochloride (PHMB) is the active ingredient in Cosmocil ®CQ. The sponges have a slit cut in them from the center of one side up through the midpoint wher a T-cut is formed. The dressing is packaged in a paper paper pouch and will be available in 2" x 2" and 4" x 4" sponge form.
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    K Number
    K002902
    Device Name
    TANDEM-CATH 10 FR. CATHETER SYSTEM, MODEL MULTIPLE CODE NUMBERS
    Manufacturer
    THE KENDALL COMPANY
    Date Cleared
    2001-04-09

    (203 days)

    Product Code
    MSD
    Regulation Number
    876.5540
    Why did this record match?
    Applicant Name (Manufacturer) :

    THE KENDALL COMPANY

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K002901
    Device Name
    KENDALL 14.5 FR MAXID CUFFED DUAL LUMEN CATHETER
    Manufacturer
    THE KENDALL COMPANY
    Date Cleared
    2001-03-28

    (191 days)

    Product Code
    MSD
    Regulation Number
    876.5540
    Why did this record match?
    Applicant Name (Manufacturer) :

    THE KENDALL COMPANY

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K003313
    Device Name
    FILAC FAS TEMP ELECTRONIC THERMOMETER
    Manufacturer
    THE KENDALL COMPANY
    Date Cleared
    2001-01-11

    (80 days)

    Product Code
    FLL
    Regulation Number
    880.2910
    Why did this record match?
    Applicant Name (Manufacturer) :

    THE KENDALL COMPANY

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K990530
    Device Name
    KERLIX MD ANTIMICROBIAL GAUZE DRESSING
    Manufacturer
    THE KENDALL COMPANY, L.P.
    Date Cleared
    2000-01-31

    (346 days)

    Product Code
    NAD
    Regulation Number
    878.4020
    Why did this record match?
    Applicant Name (Manufacturer) :

    THE KENDALL COMPANY, L

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    KERUX Antimicrobial Gauze is intended for use as a primary dressing for exuding wounds, first and second degree burns, and surgical wounds, to secure and prevent movement of a primary dressing, and as a wound packing
    Device Description
    The proposed Kerlix MD Antimicrobial Gauze Dressing is a sterile, single use, wound dressing consisting of gauze treated with Polyhexamethylene Biguanide Hydrochloride. The dressing is packaged in Tyvek/Poly pouches as well as Tyvek/Styrene trays and is available in both sponge and roll form.
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