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510(k) Data Aggregation

    K Number
    K083417
    Device Name
    INTRATEMP SOLUTION WARMER
    Manufacturer
    C CHANGE SURGICAL LLC
    Date Cleared
    2009-01-13

    (56 days)

    Product Code
    LHC
    Regulation Number
    890.5950
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    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The IntraTemp™ Solution Warmer (TCT-6LW) is designed to warm and maintain the temperature of surgical solutions prior to their use.
    Device Description
    Not Found
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    K Number
    K080609
    Device Name
    SWC/DWC WARMING CABINETS
    Manufacturer
    MAC MEDICAL
    Date Cleared
    2008-06-13

    (102 days)

    Product Code
    LHC
    Regulation Number
    890.5950
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    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    These warming cabinets are designed to store, warm, and maintain the recommended temperature of irrigation solutions prior to use.
    Device Description
    These devices are 120 or 220 V Ac powered warming cabinets designed to store, warm, and maintain the recommended temperature of irrigation solutions prior to use. The particular cabinet configuration can be deduced from its model number: SWC = Single Warming Cabinet. DWC = Dual Warming Cabinet. G = Glass Door The temperature ranges and capacities vary according to model but all have: Adjustable Temperature Range Digital Control Dual Display Push Button Operation Rapid Warm Time High Accuracy.
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    K Number
    K050524
    Device Name
    EZ-IV MEDICAL PAD WARMING UNIT, MODEL 1000
    Manufacturer
    MARDA MEDICAL, INC.
    Date Cleared
    2005-09-14

    (196 days)

    Product Code
    IRQ
    Regulation Number
    890.5950
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    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The EZ-IV Medical Pad Warming Unit is intended to warm alcohol and povidone iodine skin cleansing pads for use in gaining venous access during intravenous fluid and / or medication administration and to facilitate phlebotomy procedures.
    Device Description
    The EZ-IV Medical Pad Warming Unit, is a compact, portable, tabletop size medical device, used to warm factory sealed medical prep pads (alcohol and povidone iodine), with a pre-set maximum temperature of 55° C. A lid covers the unit to minimize any heat loss from the medical pads. Inside the unit are four individual compartments, in which the sealed pads are placed. Each compartment has it's own, inner lid. The front of the device has a membrane keypad to control the device function.
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    K Number
    K051819
    Device Name
    C CHANGE SOLUTION WARMER
    Manufacturer
    C CHANGE SURGICAL LLC
    Date Cleared
    2005-08-15

    (41 days)

    Product Code
    LHC
    Regulation Number
    890.5950
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    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Integrity Spine Lumbar Interbody Fusion System is indicated for intervertebral body fusion of the lumbar spine, from L2 to S1, in skeletally mature patients who have had six months of non-operative treatment. The device is intended for use at either one level or two contiguous levels for the treatment of degenerative disc disease (DDD) with up to Grade I spondylolisthesis at the involved level(s). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. These patients may have had a previous non-fusion spinal surgery at the involved spinal level(s). The device system is designed for use with supplemental fixation and with autograft to facilitate fusion.
    Device Description
    The Integrity Spine Lumbar Interbody Fusion System will be offered in various device configurations based on surgical approach and patient anatomy. The Integrity Spine lumbar interbody fusion device(s) mav be implanted: - bi-laterally in pairs via a posterior (PLIF) approach; - as a single device via an oblique (OLIF) approach: a - as a single device via a transforaminal (TLIF) approach: or - - as as a single device via an anterior or anterolateral (ALIF) approach. The System is implanted using a combination of device specific and universal class I instruments manufactured from stainless steel materials that conform to ASTM F899. The implant components are made of polyether ether ketone (PEEK Zeniva ZA-500) that conforms to ASTM F2026. Additionally, the devices contain tantalum markers (ASTM F560) to assist the surgeon with proper placement of the device.
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    K Number
    K023282
    Device Name
    ORS-3000LD
    Manufacturer
    O.R. SOLUTIONS, INC.
    Date Cleared
    2002-11-13

    (43 days)

    Product Code
    LHC
    Regulation Number
    890.5950
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    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The ORS-3000LD is an equipment cover for the ORS-1075LD Hush-Slush® machine. This is a single use product supplied sterile. This device is intended for use during various surgeries where slush and/or cold solution is required.
    Device Description
    The ORS-3000LD is an equipment cover for the ORS-1075LD Hush-Slush® machine. This is a single use product supplied sterile.
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    K Number
    K023283
    Device Name
    1075LD HUSH-SLUSH
    Manufacturer
    O.R. SOLUTIONS, INC.
    Date Cleared
    2002-11-13

    (43 days)

    Product Code
    LHC
    Regulation Number
    890.5950
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    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The ORS-1075LD is designed to cool surgical irrigation solutions and/or create slush.
    Device Description
    Not Found
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    K Number
    K021288
    Device Name
    ORS-1000LD
    Manufacturer
    O.R. SOLUTIONS, INC.
    Date Cleared
    2002-06-27

    (65 days)

    Product Code
    LHC
    Regulation Number
    890.5950
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    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The ORS-1000LD Leak Detection Drape is an equipment cover for the ORS-2000LD Solution Warmer. This is a single use product supplied sterile. This device is intended for use during various surgeries where warm irrigation solution is required.
    Device Description
    The ORS-1000LD Leak Detection Drape is an equipment cover for the ORS-2000LD Solution Warmer. This is a single use product supplied sterile.
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    K Number
    K021289
    Device Name
    WARMER 2000LD
    Manufacturer
    O.R. SOLUTIONS, INC.
    Date Cleared
    2002-06-26

    (64 days)

    Product Code
    LHC
    Regulation Number
    890.5950
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    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The ORS-2000LD is designed to warm and maintain the temperature of surgical solutions prior to their use.
    Device Description
    Not Found
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    K Number
    K002859
    Device Name
    SSW-STERILE SOLUTION WARMER
    Manufacturer
    KMI KOLSTER METHODS, INC.
    Date Cleared
    2000-11-16

    (64 days)

    Product Code
    LHC
    Regulation Number
    890.5950
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    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The K.M.I. SSW Sterile Solution Warmer is intended for the administration of sterile solutions at a controlled temperature drawn from containers using K.M.I. DIK system administration set. The "K" pump is also used in conjunction with this device.
    Device Description
    Not Found
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    K Number
    K965136
    Device Name
    UROSURGE UROTHERM FLUID WARMING SYSTEM
    Manufacturer
    PRINCETON REGULATORY ASSOC.
    Date Cleared
    1998-10-16

    (662 days)

    Product Code
    LHC
    Regulation Number
    890.5950
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    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The UroSurge UroTherm™ Fluid Warming System is intended to varm sterile irrigating solutions to normothermic temperatures (37°C) for use in medical/surgical procedures. Not for use with blood or blood products.
    Device Description
    UroSurge UroTherm™ Fluid Warning System
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