Search Filters

Search Results

Found 14 results

510(k) Data Aggregation

    K Number
    K071875
    Device Name
    V-CATH POLY PICC
    Manufacturer
    HDC CORP.
    Date Cleared
    2007-11-05

    (122 days)

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

    HDC CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Power-V PICC is indicated for patients that require repeated venous access for infusion or injection therapy. The Power-V PICC is indicated for peripheral access to the central venous system for intravenous therapy. The Power-V PICC is indicated for dwell times less than or greater than 30 days. The maximum recommended infusion rate is 5 ml/sec. The maximum pressure of power injectors used with the Power-V PICC catheter may not exceed 300 psi.
    Device Description
    The Power-V PICC is a family of peripherally inserted central venous catheters designed to allow for contrast media studies. The catheters, made of radiopaque polyurethane tubing, are inserted pcriphcrally. Each Power-V PICC has a kink resistant, reverse tapered catheter design. The Power-V PICC is indicated for dwell times greater than 30 days. The Power-V PICC catheter assemblies have been tested to withstand power injection of worst-case viscosity injection media at 5 cc/sec with a maximum power injection pressure of 300 psi (scc Appendix B). The catheter is supplied sterile and non-pyrogenic in a variety of kit configurations (scc Appendix C). The Power-V PICC is illustrated in the drawings at the end of this section. The Power-V PICC product line has catheters in 4 Fr and 5 Fr single lumen and 5 Fr and 6 Fr dual lumen. All catheters are 60 cm long. The catheters are attached to an injection-molded polyurethane hub that has extension legs with luer lock fittings for access attachment.
    Ask a Question
    K Number
    K023342
    Device Name
    NEURO-TRACE III KIT, NEURO-TRACE III REGIONAL BLOCK CABLE, NEURO-TRACE III NERVE MAPPING PROBE, NEURO-TRACE III NERVE BG
    Manufacturer
    HDC CORP.
    Date Cleared
    2004-03-02

    (512 days)

    Product Code
    KOI
    Regulation Number
    868.2775
    Why did this record match?
    Applicant Name (Manufacturer) :

    HDC CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The NeuroTrace III can be used as an objective monitor using accelerometry for measuring the muscle contraction following stimulation of the acceleromotive motor neuron, as a peripheral nerve stimulator (without the objective respecific first in a subjective monitoring and for locating specific nerves. It is measuring raneword 191 basyolock procedures to obtain effective regional anesthesia blocks.
    Device Description
    Not Found
    Ask a Question
    K Number
    K033853
    Device Name
    MODIFICATION TO V-CATH POLY PICC
    Manufacturer
    HDC CORP.
    Date Cleared
    2004-01-14

    (34 days)

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

    HDC CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The V-Cath® Poly PICC is indicated for the patient that requires repeated access for infusion or injection therapy. It can also be used for blood sampling although a 4FR or larger catheter is recommended.
    Device Description
    Not Found
    Ask a Question
    K Number
    K032404
    Device Name
    SELDINGER SAFETY NEEDLE INTRODUCER
    Manufacturer
    HDC CORP.
    Date Cleared
    2003-09-10

    (37 days)

    Product Code
    DYB
    Regulation Number
    870.1340
    Why did this record match?
    Applicant Name (Manufacturer) :

    HDC CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Seldinger Safety Needle Introducer incorporates a retractable needle safety mechanism to minimize needle stick injuries when used to introduce a guidewire (.018 inches maximum) into the vascular system.
    Device Description
    Not Found
    Ask a Question
    K Number
    K022752
    Device Name
    PANDIN CONTINUOUS NERVE STIMULATING CATHETER, MODELS 561-18-05, 561-18-09, 561-18-15, 562-18-05, 562-18-09 & 562-18-15
    Manufacturer
    HDC CORP.
    Date Cleared
    2003-09-09

    (386 days)

    Product Code
    CAZ
    Regulation Number
    868.5140
    Why did this record match?
    Applicant Name (Manufacturer) :

    HDC CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Pandin Continuous Nerve Stimulating Catheter permits placement of catheters next to nerves and nerve plexus for continuous nerve block anesthesia or analgesia techniques. It is indicated for use up to 72 hours.
    Device Description
    Not Found
    Ask a Question
    K Number
    K022099
    Device Name
    SAFE-T-PEEL SAFETY NEEDLE/INTRODUCER, MODELS 350-300 S, 360-300'S,380-300'S,390-300'S
    Manufacturer
    HDC CORP.
    Date Cleared
    2002-09-20

    (85 days)

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

    HDC CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Safe-T-Peel® Safety Needle Introducer is used to facilitate placement of a peripherally inserted intravenous catheter, through the skin into a vein and when used according to the Instructions For Use (IFU) may reduce the risk of an accidental needle stick.
    Device Description
    single patient, single use, stainless steel needle introducers with splittable sheaths, intended to facilitate the placement of Peripherally Inserted Catheters (PICs). Additionally the Safe-T-Peel® Safetv Needle/Introducer contains a splittable plastic sheath identical to the one used in the TFX Medical Introducer Assembly (K993191).
    Ask a Question
    K Number
    K010425
    Device Name
    EPIDURAL CATHETER WITH CONNECTOR (AND ACCESSORY)
    Manufacturer
    HDC CORP.
    Date Cleared
    2001-03-15

    (30 days)

    Product Code
    KNF
    Regulation Number
    884.4160
    Why did this record match?
    Applicant Name (Manufacturer) :

    HDC CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
    Ask a Question
    K Number
    K994059
    Device Name
    CLA KIT (CONTINUOUS LOCAL ANESTHESIA), MODEL 551-17, 551-10, 551-07
    Manufacturer
    HDC CORP.
    Date Cleared
    2000-10-13

    (319 days)

    Product Code
    CAZ
    Regulation Number
    868.5140
    Why did this record match?
    Applicant Name (Manufacturer) :

    HDC CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The CLA Kit (Nerve Block Infusion Kit) is intended for the injection of local anesthetic to achieve peripheral nerve conduction blocks, by use of an insulated hollow needle for electrical stimulation to locate peripheral nerves, and the injection of local anesthetic either directly through the needle, or for up to 72 hours via a catheter inserted through the needle.
    Device Description
    CLA Kit (Nerve Block Infusion Kit)
    Ask a Question
    K Number
    K002770
    Device Name
    IBIS CHEMO-PORT IMPLANTABLE VASCULAR ACCESS SYSTEM, MODEL 700-08-10,700-08-11,700-08-12,700-08-15,700-08-16,735-08-10
    Manufacturer
    HDC CORP.
    Date Cleared
    2000-09-26

    (20 days)

    Product Code
    LJT
    Regulation Number
    880.5965
    Why did this record match?
    Applicant Name (Manufacturer) :

    HDC CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
    Ask a Question
    K Number
    K983119
    Device Name
    ENTERO-TEST HP, MODEL #102-01
    Manufacturer
    HDC CORP.
    Date Cleared
    1999-03-15

    (188 days)

    Product Code
    LIO
    Regulation Number
    866.2900
    Why did this record match?
    Applicant Name (Manufacturer) :

    HDC CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Entero-Test® HP is an in-vitro diagnostic device to be used for the collection of fluid/mucous containing Helicobacter pylori from the upper gastrointestinal tract of adults. The device consists of a nylon thread, 90cm in length, coiled inside a #00 gelatin pharmaceutical capsule.
    Device Description
    The Entero-Test® HP is collection device encased in a gelatin capsule. It can be used to collect fluids/mucous in the upper gastrointestinal tract of adults. A pH stick and a color chart are included in each package for the purpose of identifying the pH of the fluids/mucous.
    Ask a Question

    Page 1 of 2