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510(k) Data Aggregation

    K Number
    K991235
    Device Name
    SOFTRANS TEMP INTRAUTERINE PRESSURE CATHETER SYSTEM (IUP 5000, SOFTRANS TEMP IUPC)
    Manufacturer
    LUDLOW TECHNICAL PRODUCTS
    Date Cleared
    1999-07-08

    (87 days)

    Product Code
    KXO
    Regulation Number
    884.2700
    Why did this record match?
    Applicant Name (Manufacturer) :

    LUDLOW TECHNICAL PRODUCTS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Softrans Temp™ IUPC System may be used during the interpartum period to monitor intrauterine pressure, to monitor intrauterine temperature, to amnioinfuse or to perform amniotic fluid sampling.
    Device Description
    An intrauterine catheter with a pressure transducer at the tip, a thermistor located near the tip, a port for amnioinfusion and amniotic fluid sampling, signal wires, and an introducer which is removed after placement. System includes a reusable cable that contains a rezero mechanism, cable check and temperature display unit. An attachment strap is provided. Catheters are packaged within a PETG tray with a heat sealed tyvek lid. Unit of sale is a case of 10 IUPC's. Cables are packaged in protective wrap and corrugated shippers.
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    K Number
    K973110
    Device Name
    LUDLOW TECHNICAL PRODUCTS, ELECTRODE, ELECTROSURGICAL, DISPOSABLE PEDIATRIC DISPERSIVE ELECTRODES; WITH AND WITHOUT CORD
    Manufacturer
    LUDLOW TECHNICAL PRODUCTS
    Date Cleared
    1997-10-21

    (62 days)

    Product Code
    GEI
    Regulation Number
    878.4400
    Why did this record match?
    Applicant Name (Manufacturer) :

    LUDLOW TECHNICAL PRODUCTS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The ProCam Medical Pediatric Dispersive Electrode is indicated for use in monopolar electrosurgical applications as a non-sterile, disposable device, for single patient use, only. It is intended to disperse the current as it is removed from the patient during the electrosurgical process. By connecting to the electrosurgical generator, via the pre-attached cable or re-useable cable, the circuit is completed causing successful cutting or coagulation in the patient. This electrode is intended for use in electrosurgery on pediatric patients weighing 25 lbs. or less and with the generator power settings less than 150 watts. The Pediatric Dispersive Electrode is not indicated for use for high-powered procedures such as transurethral resection (TUR). The device will work with any standard generator.
    Device Description
    The function of the Ludlow Technical Products pediatric ESD electrodes is to complete the electrosurgical circuit between the patient, the active electrode, and the generator. The products are the same in their construction using conductive adhesive hydrogel along with a foil/polyester conductor plate and a foam insulation backing.
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    K Number
    K972646
    Device Name
    AD-HEAL HYDROGEL DRESSING, VARIOUS SIZES
    Manufacturer
    LUDLOW TECHNICAL PRODUCTS
    Date Cleared
    1997-08-21

    (37 days)

    Product Code
    NAE, MGQ
    Regulation Number
    878.4022
    Why did this record match?
    Applicant Name (Manufacturer) :

    LUDLOW TECHNICAL PRODUCTS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    This hydrogel dressing is a sterile wound dressing for the management of partial thickness wounds, first and second degree burns, donor sites and superficial injuries. Ad-Heal™ Bydrogel Dressing is indicated for: First and Second Degree Burns Partial Thickness Wounds Donor Sites Pressure Ulcers Abrasions Note: Ad-Healm is not indicated for full thickness or infected wounds or for third degree burns. This is a disposable, short term (less than 72 hours between changes) device for single patient use
    Device Description
    This hydrogel dressing is a sterile wound dressing for the management of partial thickness wounds, first and second degree burns, donor sites and superficial injuries. This is a disposable, short term (less than 72 hours between changes) device for single patient use
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    K Number
    K964401
    Device Name
    KENDALL-LTP DISPOSABLE TEMPERATURE PROBES (DTP1,DTP2,DTP3,DTP4)
    Manufacturer
    LUDLOW TECHNICAL PRODUCTS
    Date Cleared
    1997-02-06

    (94 days)

    Product Code
    FMT
    Regulation Number
    880.5130
    Why did this record match?
    Applicant Name (Manufacturer) :

    LUDLOW TECHNICAL PRODUCTS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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