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510(k) Data Aggregation

    K Number
    K100635
    Device Name
    ARROWGARD EVOLUTION ANTIMICROBIAL PERIPHERALLY INSERTED CENTRAL CATHETER (PICC) MODEL: S-44041-002, S-45041-002, S-45504
    Manufacturer
    ARROW INTL., INC.
    Date Cleared
    2010-08-27

    (175 days)

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

    ARROW INTL., INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Arrow Antimicrobial Pressure Injectable PICC is indicated for short-term or longterm peripheral access to the central venous system for intravenous therapy, blood sampling, infusion, pressure injection of contrast media, and allows for central venous pressure monitoring. The maximum pressure of pressure injector equipment used with the Arrow Antimicrobial Pressure Injectable PICC may not exceed 300 psi. Antimicrobial treatment on the external surface of the catheter body as well as the entire fluid pathway of the catheter has been shown to be effective in reducing microbial colonization. Antimicrobial effectiveness was evaluated using in vitro methods, and no correlation between in vitro and clinical outcome has currently been ascertained. It is not intended to be used for the treatment of existing infections.
    Device Description
    The Arrow Antimicrobial Pressure Injectable PICC is a short-term or long-term, single use catheter designed to provide access to the central venous system. It consists of a non-tapered, radiopaque polyurethane extruded catheter body with a softer, contoured Blue Flex Tip. The catheter is available in 4.5 Fr. single lumen and 5.5 Fr. double lumen configurations with usable lengths of 40 - 55 cm. The catheters can be used for the injection of contrast media. The maximum recommended infusion rate is 5 mL/sec. The external catheter body and the internal fluid path of the device are treated with Chlorhexidine based antimicrobial technology. The catheters will be packaged sterile in both nursing and radiology The canoters will be passfigurations will include components to facilitate insertion. .
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    K Number
    K093050
    Device Name
    ARROW SELDINGER ARTERIAL CATHERIZATION DEVICES, MODELS EX SAC 00520
    Manufacturer
    ARROW INTL., INC.
    Date Cleared
    2009-12-18

    (79 days)

    Product Code
    DQY, DQX
    Regulation Number
    870.1250
    Why did this record match?
    Applicant Name (Manufacturer) :

    ARROW INTL., INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Arrow ® Seldinger Arterial Catheterization Devices permit access to the peripheral arterial circulation or to other small vessels.
    Device Description
    The Arrow Seldinger arterial catheterization devices are comprised of an introducer needle, a spring wire guide, and an arterial catheter assembly. The catheter assembly consists of a polyurethane arterial catheter molded to a winged catheter juncture hub. An extension tubing segment is molded to the proximal end of the winged catheter hub. The proximal end of the extension tubing segment is molded to a luer-locking hub. A slide clamp is provided on the extension segment.
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    K Number
    K071491
    Device Name
    ARROW INTERNATIONAL, INC., SURGICAL DRAPES
    Manufacturer
    ARROW INTL., INC.
    Date Cleared
    2007-10-10

    (133 days)

    Product Code
    KKX
    Regulation Number
    878.4370
    Why did this record match?
    Applicant Name (Manufacturer) :

    ARROW INTL., INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Arrow Surgical Drapes are intended to be used as a protective patient covering, such as to isolate a site of surgical incision from microbial and other contamination.
    Device Description
    Arrow Surgical Drapes are sterile, disposable patient coverings for use in surgical procedures. They are composed of one or more of the following materials: Barrier, Absorbent, and Repellant materials. They may incorporate one or more fenestration openings for surgical site access and can also include medical grade patient fixation adhesive.
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    K Number
    K071998
    Device Name
    ARROW ECHOGENIC INTRODUCER NEEDLE COMPONENT
    Manufacturer
    ARROW INTL., INC.
    Date Cleared
    2007-09-26

    (65 days)

    Product Code
    FMI
    Regulation Number
    880.5570
    Why did this record match?
    Applicant Name (Manufacturer) :

    ARROW INTL., INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Arrow Echogenic Introducer Needle allows access to the vascular system for the introduction of a guidewire to facilitate catheter placement.
    Device Description
    The Arrow Echogenic Introducer Needle has the following characteristics: Outside Diameter = 18Ga - 21Ga Inside Diameter = 0.0240 - 0.042 in. Usable lengths of 1 ½ - 2 ¾ in. (3.81 - 7cm) Grit-blast echogenic surface treatment
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    K Number
    K071111
    Device Name
    NON-ABSORBABLE SILK SUTURE
    Manufacturer
    ARROW INTL., INC.
    Date Cleared
    2007-07-17

    (88 days)

    Product Code
    GAP
    Regulation Number
    878.5030
    Why did this record match?
    Applicant Name (Manufacturer) :

    ARROW INTL., INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The non-absorbable silk suture is intended for use in general soft tissue approximation, excluding use in cardiovascular, ophthalmic and neurological tissues.
    Device Description
    The Arrow Non-Absorbable Silk Suture has the following characteristics: Black, braided silk suture thread of '000' (Metric 2) diameter, 30" (75 cm) suture thread length, Pre-attached, straight, stainless steel needle, 2-3/8" (60 mm) needle length
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    K Number
    K060309
    Device Name
    AUTOCAT INTRA-AORTIC BALLOON PUMP SERIES
    Manufacturer
    ARROW INTL., INC.
    Date Cleared
    2006-04-06

    (58 days)

    Product Code
    DSP
    Regulation Number
    870.3535
    Why did this record match?
    Applicant Name (Manufacturer) :

    ARROW INTL., INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The AutoCAT Intra-Aortic Balloon Pump Series is clinically indicated for the following conditions: a. Acute Coronary Syndrome b. Cardiac and Non-Cardiac Surgery c. Complications of Heart Failure
    Device Description
    The Intra-Aortic Balloon Pump (IABP) provides cardiac assist therapy. The IABP provides temporary support to patients with impaired left ventricular function through the therapeutic method referred to as counterpulsation increases coronary and systemic profusion, decreasing after load (myocardial work) and decreasing preload. The AutoCAT Series IABP System utilizes computer technology to select and maintain precise IAB inflation and deflation timing and triggering based on current physiological data from the patient. The system offers two modes of operation, the Autopilot mode, where functions are automatically selected and controlled by the IABP and the Operator mode where the user has control over settings and selections.
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    K Number
    K042126
    Device Name
    PICC
    Manufacturer
    ARROW INTL., INC.
    Date Cleared
    2004-08-27

    (21 days)

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

    ARROW INTL., INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    A Peripherally inserted Central Catheter permits venous access to the central circulation through a peripheral vein. It offers an alternative method of intravenous therapy for select adult and pediatric patients.
    Device Description
    The Arrow International Peripherally Inserted Central Catheters are similar to the currently marketed Arrow Trimmable and Blue FlexTip® single and double lumen catheters. The catheter juncture has been modified to improve overall catheter strength. The hub colors and catheter labeling have changed to distinguish the new Arrow catheters. The catheter is available in lengths of 40 cm - 60 cm.
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    K Number
    K041153
    Device Name
    SHARPSAWAY II LOCKING DISPOSABLE CUP
    Manufacturer
    ARROW INTL., INC.
    Date Cleared
    2004-07-12

    (70 days)

    Product Code
    FMI
    Regulation Number
    880.5570
    Why did this record match?
    Applicant Name (Manufacturer) :

    ARROW INTL., INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Arrow SharpsAway II™ Locking Disposal Cup is intended as a single use needle protection device, which covers the end of needles after use to minimize the risk of needle sticks. This device is designed for use with 15 Ga. to 30 Ga. needles for various clinical procedures.
    Device Description
    The proposed SharpsAway II™ Locking Disposal Cup was created to help prevent needle sticks by providing a means of moving used sharps from procedure to sharps container.
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    K Number
    K040801
    Device Name
    INTRA-AORTIC BALLOON (IAB)
    Manufacturer
    ARROW INTL., INC.
    Date Cleared
    2004-05-06

    (38 days)

    Product Code
    DSP
    Regulation Number
    870.3535
    Why did this record match?
    Applicant Name (Manufacturer) :

    ARROW INTL., INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Intra-Aortic Balloon (IAB) is clinically indicated for the following conditions: a. Acute Coronary Syndrome b. Cardiac and Non-Cardiac Surgery c. Complications of Heart Failure
    Device Description
    IAB's are designed to provide cardiac assist therapy. The devices are dual lumen percutaneously inserted Intra-Aortic IAB catheters, with two independent non-communicating lumen is comprised of an inflatable bladder connected to the catheter distal tip and to the IAB tip outer surface. The inner lumen is comprised of a luer adapter connected to the proximal end of the inner lumen and to the IAB tip inner surface. The IAB inner lumen is used for placement of the device with a guidewire and the outer lumen is used to shuttle helium gas to and from the inflatable bladder. IABs are timed to inflate within the aota during the diastolic relaxation of the heart and deflate during the systolic contraction of the heart, resulting in increased blood supply to the heart muscle and decreased work load for the left ventricle.
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    K Number
    K040802
    Device Name
    HEMOSONIC 200HEMODYNAMIC MONITOR
    Manufacturer
    ARROW INTL., INC.
    Date Cleared
    2004-04-28

    (30 days)

    Product Code
    DPN
    Regulation Number
    862.3700
    Why did this record match?
    Applicant Name (Manufacturer) :

    ARROW INTL., INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The HemoSonic™ 200 can be used to observe, diagnose, evaluate, and monitor at-risk patients from 15 to 150 kg by providing hemodynamic information for determining therapeutic actions and maintaining cardiovascular stability.
    Device Description
    The probe jacket contains the acoustic gel into which the ultrasound crystals are placed. It consists of a plug rod, tip cap, hub, body, acoustic gel and tip.
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