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510(k) Data Aggregation

    K Number
    K000087
    Device Name
    MARHUKAR TRIPLE LUMEN CATHETER, MODEL 12 FR
    Manufacturer
    THE KENDAL CO.
    Date Cleared
    2000-03-17

    (65 days)

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

    THE KENDAL CO.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K990500
    Device Name
    KENDALL ULTRAMER COUDE FOLEY CATHETER, MODEL 1416C, KENDALL CURITY COUDE FOLEY CATHETER TRAY, MODEL 6946C
    Manufacturer
    THE KENDAL CO.
    Date Cleared
    1999-09-28

    (223 days)

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

    THE KENDAL CO.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Kendall Coude Foley Catheter is a urological catheter designed with a bent tip to provide transurethral access to the obstructed bladder in the male patient for irrigation and urine drainage.
    Device Description
    The Kendall Ultraner Coude Foley Catheter is a sterile, single use unological catheter composed of natural rubber latex with a 5 cc or 30cc balloon and designed with a beat tip to provide transurethral access to an obstructed bladder, for purposes of irrigation and urine drainage. The Coude catheter is exclusively used in the male patient, typically in a hospital secting. The Kendall Ultramer Coude Foley Catheters will be marketed in 12-24 French sizes.
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    K Number
    K991758
    Device Name
    MONOJECT INSULIN SYRINGE
    Manufacturer
    THE KENDAL CO.
    Date Cleared
    1999-06-14

    (21 days)

    Product Code
    FMF
    Regulation Number
    880.5860
    Why did this record match?
    Applicant Name (Manufacturer) :

    THE KENDAL CO.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    MONOJECT Insulin Syringes are used for subcutaneous injection of U-100 Insulin.
    Device Description
    Monoject Insulin Syringes are sterile, single use, disposable hypodermic syringes with permanently affixed hypodermic needles. Monoject Insulin Syringes consist of a syringe barrel, a plunger rod, and a hypodermic needle permanently affixed to the tip of the syringe with epoxy. Monoject Insulin Syringes are available in 1.0 cc (100 units), 0.5 cc (50 Units) and 0.3 cc (30 units) syringe capacities with the following sizes of hypodermic needle: 28 GA x ½ inch, 29 GA x ½ inch and 30 GA x 5/16 inch.
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    K Number
    K970969
    Device Name
    KENDALL CURITY SUPRAPUBIC CATHETER TRAY, KIT, & REPLACEMENT SET
    Manufacturer
    THE KENDAL CO.
    Date Cleared
    1997-04-23

    (37 days)

    Product Code
    KOB
    Regulation Number
    876.5090
    Why did this record match?
    Applicant Name (Manufacturer) :

    THE KENDAL CO.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Kendall CURITY Suprapubic Catheter Trays and kits are intended to provide urinary bladder drainage or irrigation by percutaneous placement of a suprapubic catheter. This is a useful method of controlling urinary bladder drainage postoperatively.
    Device Description
    The Kendall Suprapubic Catheter Trays and Kits are sterile, single use devices which are designed to provide suprapubic access to the bladder for bladder irrigation and urine drainage. The proposed device consists of 100% silicone suprapubic catheters in 10, 12 and 14 French sizes packaged with various accessories. The catheters are two-way balloon catheters having a drainage and inflation lumen.
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