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510(k) Data Aggregation

    K Number
    K232924
    Device Name
    T-Line® Hernia Mesh
    Manufacturer
    Deep Blue Medical Advances, Inc.
    Date Cleared
    2023-10-18

    (29 days)

    Product Code
    FTL
    Regulation Number
    878.3300
    Why did this record match?
    Applicant Name (Manufacturer) :

    Deep Blue Medical Advances, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The T-Line Hernia Mesh is indicated for the reinforcement of soft tissue where weakness exists for the repair of ventral hernias performed via an open onlay or sub lay approach in adults (greater than 21 years of age).
    Device Description
    The T-Line Hernia Mesh is manufactured by knitting and heat pressing standard medical grade polypropylene monofilament yarn using well-established standard processes that are used to manufacture other commercially available hernia meshes. Mesh extensions are used to apply the device to the abdominal wall. The extensions of the T-Line Hernia Meshare incorporated directly into the mesh body. The mesh design incorporates continuous, uninterrupted, seamless extensions from the mesh body to facilitate mesh securement to tissue. After knitting, needles are swaged onto the ends of the extensions to allow the extensions to be sewn into the abdominal fascia by surgeons akin to how sutures are sewn into fascia.
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    K Number
    K230227
    Device Name
    T-Line Hernia Mesh
    Manufacturer
    Deep Blue Medical Advances, Inc.
    Date Cleared
    2023-02-23

    (27 days)

    Product Code
    FTL
    Regulation Number
    878.3300
    Why did this record match?
    Applicant Name (Manufacturer) :

    Deep Blue Medical Advances, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The T-Line Hernia Mesh is indicated for the reinforcement of soft tissue where weakness exists for the repair of ventral hernias performed via an open onlay or sublay approach in adults (greater than 21 years of age).
    Device Description
    The T-Line® Hernia Mesh is manufactured by knitting and heat pressing standard medical grade polypropylene monofilament yarn using wellestablished standard processes that are used to manufacture other commercially available hernia meshes. Mesh extensions are used to apply the device to the abdominal wall. The extensions of the T-Line® Hernia Meshare incorporated directly into the mesh body. The mesh design incorporates continuous, uninterrupted, seamless extensions from the mesh body to facilitate mesh securement to tissue. After knitting, needles are swaged onto the ends of the extensions to allow the extensions to be sewn into the abdominal fascia by surgeons akin to how sutures are sewn into fascia.
    Ask a Question
    K Number
    K221556
    Device Name
    T-Line Hernia Mesh
    Manufacturer
    Deep Blue Medical Advances, Inc.
    Date Cleared
    2022-11-28

    (181 days)

    Product Code
    FTL
    Regulation Number
    878.3300
    Why did this record match?
    Applicant Name (Manufacturer) :

    Deep Blue Medical Advances, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The T-Line® Hernia Mesh is indicated for the reinforcement of soft tissue where weakness exists for the repair of ventral hernias performed via an open onlay or sublay approach in adults (greater than 21 years of age).
    Device Description
    The T-Line® Hernia Mesh is manufactured by knitting and heat pressing standard medical grade polypropylene monofilament yarn using wellestablished standard processes that are used to manufacture other commercially available hernia meshes. Mesh extensions are used to apply the device to the abdominal wall. The extensions of the T-Line® Hernia Meshare incorporated directly into the mesh body. The mesh design incorporatescontinuous, uninterrupted, seamless extensions from the mesh body to facilitate mesh securement to tissue. After knitting, needles are swaged onto the ends of the extensions to allow the extensions to be sewn into the abdominal fascia by surgeons akin to how sutures are sewn into fascia.
    Ask a Question
    K Number
    K193144
    Device Name
    T-Line Hernia Mesh
    Manufacturer
    Deep Blue Medical Advances, Inc.
    Date Cleared
    2020-03-30

    (138 days)

    Product Code
    FTL
    Regulation Number
    878.3300
    Why did this record match?
    Applicant Name (Manufacturer) :

    Deep Blue Medical Advances, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    T-LINE™ HERNIA MESH is indicated for the reinforcement of soft tissue where weakness exists for the repair of ventral hernias performed via an open onlay approach.
    Device Description
    The T-Line Hernia Mesh is manufactured by knitting and heat pressing standard medical grade polypropylene monofilament yarn using wellestablished standard processes that are used to manufacture other commercially available hernia meshes. Mesh extensions are used to apply the device to the abdominal wall. The extensions of the T-Line Hernia Mesh are incorporated directly into the mesh body. The mesh design incorporates continuous, uninterrupted, seamless extensions from the mesh body to facilitate mesh securement to tissue. After knitting, needles are swaqed onto the ends of the extensions to allow the extensions to be sewn into the abdominal fascia by surgeons akin to how sutures are sewn into fascia.
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    K Number
    K041185
    Device Name
    TORSO ARRAY COIL, MODEL 558GE-64
    Manufacturer
    IGC-MEDICAL ADVANCES, INC.
    Date Cleared
    2004-05-14

    (8 days)

    Product Code
    MOS
    Regulation Number
    892.1000
    Why did this record match?
    Applicant Name (Manufacturer) :

    IGC-MEDICAL ADVANCES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Magnetic resonance imaging (MRI) and magnetic resonance angiography (MRA) of the Musculoskeletal structures, soft tissue and vascular structures of the torso, pelvis, and abdomen.
    Device Description
    Model 558GE-64 Torso Array Coil. Compatible with GE Signa EXCITE 1.5T MR Systems.
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    K Number
    K040640
    Device Name
    MODEL 475 - 8 CHANNEL T/R PHASED ARRAY LOWER EXTREMITY COIL
    Manufacturer
    IGC-MEDICAL ADVANCES, INC.
    Date Cleared
    2004-03-22

    (12 days)

    Product Code
    MOS
    Regulation Number
    892.1000
    Why did this record match?
    Applicant Name (Manufacturer) :

    IGC-MEDICAL ADVANCES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Magnetic resonance imaging (MRI) of the musculoskeletal structures, soft tissue and vascular structures of the lower extremities.
    Device Description
    Model 475 8 Channel T/R Phased Array Lower Extremity Coil. Compatible with GE and Siemens 1.5T and 3.0T MR Systems.
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    K Number
    K033292
    Device Name
    AIRIS-ELITE RAPID BODY COIL, MODEL 554HI-12
    Manufacturer
    IGC-MEDICAL ADVANCES, INC.
    Date Cleared
    2003-11-26

    (43 days)

    Product Code
    MOS
    Regulation Number
    892.1000
    Why did this record match?
    Applicant Name (Manufacturer) :

    IGC-MEDICAL ADVANCES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Magnetic resonance imaging (MRI) and magnetic resonance angiography (MRA) of the musculoskeletal structures, soft tissue and vascular structures within the anatomic regions from the chest to the pelvic region.
    Device Description
    Model 554HI-12 RAPID Body Coil. Compatible with Hitachi AIRIS-Elite MR Systems.
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    K Number
    K023848
    Device Name
    MODEL 675GE-64 PERIPHERAL VASCULAR COIL CONSISTING OF MODEL 665GE-64: LOWER EXTREMITY FLEXIBLE ARRAY AND MODEL 538GE-64:
    Manufacturer
    IGC-MEDICAL ADVANCES, INC.
    Date Cleared
    2003-02-14

    (87 days)

    Product Code
    MOS
    Regulation Number
    892.1000
    Why did this record match?
    Applicant Name (Manufacturer) :

    IGC-MEDICAL ADVANCES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Magnetic resonance imaging (MRI) and magnetic resonance angiography (MRA) of adults and pediatrics of musculo-skeletal structures, soft tissue and vascular structures (mid-abdomen to mid-foot).
    Device Description
    Model 675GE-64 Peripheral Vascular Coil consisting of Model 665GE-64 Lower Extremity Flexible Array and Model 538GE-64 Medium General Purpose Flex Coil. Compatible with GE Signa 1.5T MRI systems with Phased Array option.
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    K Number
    K023084
    Device Name
    MODEL 472GE-128: QUADRATURE LOWER EXTREMITY COIL
    Manufacturer
    MEDICAL ADVANCES, INC.
    Date Cleared
    2002-12-16

    (90 days)

    Product Code
    MOS
    Regulation Number
    892.1000
    Why did this record match?
    Applicant Name (Manufacturer) :

    MEDICAL ADVANCES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Magnetic resonance imaging (MRI) and magnetic resonance angiography (MRA) of the musculoskeletal structures, soft tissue and vascular structures of the lower extremities.
    Device Description
    Model 472GE-128 Quadrature Lower Extremity Coil. Compatible with GE Signa 3.0T MR Systems. Magnetic Resonance Imaging Coil.
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    K Number
    K021433
    Device Name
    MODEL 415PH-64/42: PHASED ARRAY SHOULDER COIL
    Manufacturer
    MEDICAL ADVANCES, INC.
    Date Cleared
    2002-06-13

    (38 days)

    Product Code
    MOS
    Regulation Number
    892.1000
    Why did this record match?
    Applicant Name (Manufacturer) :

    MEDICAL ADVANCES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Magnetic resonance imaging (MRI) of the shoulder.
    Device Description
    Model 415PH-64/42: Phased Array Shoulder Coil With Model 855PH: Synergy MultiConnect. Compatible with a Philips 1.5T/1.0T MRI System. Magnetic Resonance Imaging Coil.
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