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510(k) Data Aggregation

    K Number
    K191470
    Device Name
    C-CAT Anaesthesia Catheter kit
    Manufacturer
    Cimpax ApS
    Date Cleared
    2019-10-25

    (144 days)

    Product Code
    BSO
    Regulation Number
    868.5120
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    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The CIMPAX C-CAT Anesthesia Catheter, along with related accessory devices, is intended for the delivery of continuous or intermittent delivery of medication (such as local anesthetics or narcotics) to or around surgical wound sites for preoperative and postoperative pain management. Routes of administration may be intraoperative or percutaneous.
    Device Description
    The CIMPAX® C-CAT catheter kit is a sterile, single use, closed tip, multi-perforated catheter with a specified fenestrated length that incoporates micro-holes placed in a spiral pattern to provide 360° drug distribution. Additonally the CIMPAX® C-CAT is radiopaque and has four graduated distance markings along the catheter length for positional reference. The kit is intended for adult patients requiring the delivery of contiguous or intermittent delivery of medication (such as local anesthetics or narcotics) to or around surgical wound sites for preoperative and postoperative pain management or as perineural delivery. Routes of administration may be intraoperative or percutaneous. The device is intended to be used in healthcare /hospital facilities. The CIMPAX® C-CAT catheter is a multi-perforated catheter supplied in a kit which contains components for catheter placement. The drug infusion segment is placed between the blue tip of the catheter and the first blue marking after the tip. The catheter is designed with a specified fenestrated length that incoporates micro-holes placed in a spiral pattern to provide 360° drug distribution. Additonally the CIMPAX® C-CAT is radiopaque and has four graduated distance markings along the catheter length for positional reference. Attached to the catheter is a standard female luer lock that is compatible with and can be used with infusion pumps as well as with syringes for bolus injections with standard make luer connections. The catheter is placed usually through an incision or wound in order to provide continuous or intermittent administration of local anesthetic to the area affected. This allows only the local nerve endings (pain receptors) to be anesthetized as opposed to giving a systemic pain relief medication to the patient.
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    K Number
    K170003
    Device Name
    Zip 4 Skin Closure Device
    Manufacturer
    ZipLine Medical, Inc.
    Date Cleared
    2017-08-18

    (227 days)

    Product Code
    PYO
    Regulation Number
    880.5240
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    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Zip 4 Skin Closure Device is indicated for skin closure of minor lacerations. The Zip 4 Skin Closure Device may be sold direct to consumers (OTC).
    Device Description
    The Zip® 4 Skin Closure Device is a single-use non-invasive skin closure device. A single Zip 4 device may be used to close wounds up to 4 cm (1.5 inches) in length from minor cuts or minor lacerations. The device is applied to clean, dry skin prior to skin closure, remains on the skin during wound healing, and may be removed by lifting one edge and peeling the device from the skin. The device is made of polymeric materials and utilizes a non-latex, pressure sensitive skin adhesive. The device contents are provided sterile in an intact and unopened package.
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    K Number
    K102238
    Device Name
    ARROW(R) NEXTSTEP TM ANTEGRADE CHRONIC HEMODIALYSIS CATHETER
    Manufacturer
    Teleflex Medical, Inc.
    Date Cleared
    2011-02-01

    (176 days)

    Product Code
    MSD
    Regulation Number
    876.5540
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    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Arrow® NextStep™ Antegrade Chronic Hemodialysis Catheter is indicated for use in attaining long-term vascular access for hemodialysis and apheresis. The Arrow NextStep™ Antegrade Catheter is inserted percutaneously and is preferentially placed into the internal jugular (IJ) vein. Alternately, this catheter may be inserted into the subclavian vein although the jugular vein is the preferred site. Catheters greater than 40 cm are intended for femoral vein insertion. The Arrow® NextStep™ Antegrade catheter is intended for use in adult patients.
    Device Description
    The Arrow® NextStep™ Antegrade Chronic Hemodialysis Catheter is a 15 Fr, 2 lumen, one piece Carbothane catheter with a preloaded stylet and step tip designed for antegrade placement. The catheter is available in multiple lengths. The procedure kit includes the necessary accessories to correctly insert the catheter.
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    K Number
    K080524
    Device Name
    CENTURION SORBAVIEW OTC
    Manufacturer
    TRI-STATE HOSPITAL SUPPLY CORP.
    Date Cleared
    2008-04-23

    (57 days)

    Product Code
    FRO, KGX
    Regulation Number
    N/A
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    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Centurion® SorbaView® OTC dressings are intended for medical purposes to cover and protect wounds, hold together the skin edges of a wound, support an injured part of the body, or to secure objects to the skin. This device is intended for lay or prescription use by pediatric or adult patients.
    Device Description
    Sorba View® dressings are highly permeable, self-adhesive, transparent film dressings that are of multi-layer construction. The multi-layer construction consists of: - Polyurethane film, . - . Solvent-spun cellulose, - . Medical grade adhesive, - ◆ Non-woven fabric, and - Kraft liner with silicone release coating. .
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    K Number
    K042359
    Device Name
    SUBDURAL EVACUATING PORT SYSTEM CRANIAL ACCESS KIT (SEPS-CA), (SEPS-CAL), (SEPS-CAND),MODELS 11-0401 CA, 11-0401-CAL
    Manufacturer
    MEDICAL DESIGNS, LLC
    Date Cleared
    2004-11-17

    (78 days)

    Product Code
    JXG
    Regulation Number
    882.5550
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    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Use of the Subdural Evacuating Port System Cranial Access Kit is indicated when access to and evacuation of a cranial subacute or chronic hematoma or hygroma is necessary. The Subdural Evacuating Port System Cranial Access Kit is intended for drainage of subdural fluid accumulations such as hygromas and chronic or subacute hematomas to an external suction reservoir. The Subdural Evacuating Port System Cranial Access Kit is also intended for draining air and fluids from the subdural space immediately following craniotomy procedures performed to remove a chronic or subacute subdural hematoma.
    Device Description
    The Subdural Evacuating Port System Cranial Access Kit is indicated when access to the subdural space and evacuation of a cranial subacute or chronic hematoma or hygroma is necessary. The Subdural Evacuating Port System Cranial Access Kit consists of surgical instruments and accessories used for draining subdural fluid accumulations such as hygromas and liquid-state subdural hematomas to an external suction reservoir without touching the brain. Utilizing a minimally invasive technique, the Subdural Evacuating Port System Cranial Access Kit's "SEPS Components" are designed to promote gradual brain reexpansion by creating a low homogeneous negative pressure throughout the subdural space as fluid is drained to an external suction reservoir. The completeness of the Subdural Evacuating Port System Cranial Access Kit saves time and eliminates the need to gather supplies; this convenience can be critical in an emergency situation. The Subdural Evacuating Port System Cranial Access Kit is available in three (3) kit configurations: 1. SEPS-CA, Catalog # 11-0401-CA (Standard Kit) 2. SEPS-CAL, Catalog # 11-0401-CAL (Standard Kit with Lidocaine w/epinephrine) 3. SEPS-CAND, Catalog # 11-0401-CAND (Standard Kit without Lidocaine, ChloraPrep® One-Step, or PVP (Povidone-Iodine) ointment -- no drugs).
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    K Number
    K032463
    Device Name
    CURAD SILVER BANDAGE
    Manufacturer
    BEIERSDORF AG
    Date Cleared
    2004-02-10

    (183 days)

    Product Code
    FRO
    Regulation Number
    N/A
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    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The CURAD® Silver Bandage is indicated for first aid to help in minor abrasions, cuts, lacerations, scrapes, and scalds.
    Device Description
    The CURAD® Silver Bandage is an adhesive bandage that includes silver in the wound pad. The bandage covers the wound to create a protected environment. At the same time, silver ions reduce bacterial growth in the wound pad.
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    K Number
    K964029
    Device Name
    EMERGENCY RELIEF KIT SYSTEM
    Manufacturer
    BAXTER HEALTHCARE CORP.
    Date Cleared
    1997-03-17

    (161 days)

    Product Code
    LRR
    Regulation Number
    N/A
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    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Baxter Emergency Relief TM System consists of color-coded mini first aid kits. Each kit is intended to be used as a basic first aid treatment for various emergency situations, while seeking further professional medical assistance.
    Device Description
    The Baxter Emergency Relief ™ System is designed as one large unit which houses various first aid kits Each mini kit contains various individual components traditionally used for first aid treatment. Each individual component is a finished good with an established regulatory path where applicable. All components are purchased as finished goods and packaged in the appropriate mini kit, including direction for use inserts. All direction for use inserts correspond to the instruction manual accompanying the system.
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    K Number
    K955270
    Device Name
    TAPE & BANDAGE, ADHESIVE
    Manufacturer
    ROBERT R. STEVENS
    Date Cleared
    1996-08-08

    (267 days)

    Product Code
    DXC
    Regulation Number
    870.4450
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    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Cutaneous Compression Device for General Hospital Use.
    Device Description
    Tape and Bandage, Adhesive
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