Search Results
Found 27 results
510(k) Data Aggregation
K Number
K232924Device Name
T-Line® Hernia Mesh
Manufacturer
Deep Blue Medical Advances, Inc.
Date Cleared
2023-10-18
(29 days)
Product Code
FTL
Regulation Number
878.3300Why 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
K230227Device Name
T-Line Hernia Mesh
Manufacturer
Deep Blue Medical Advances, Inc.
Date Cleared
2023-02-23
(27 days)
Product Code
FTL
Regulation Number
878.3300Why 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.
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K Number
K221556Device Name
T-Line Hernia Mesh
Manufacturer
Deep Blue Medical Advances, Inc.
Date Cleared
2022-11-28
(181 days)
Product Code
FTL
Regulation Number
878.3300Why 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.
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K Number
K193144Device Name
T-Line Hernia Mesh
Manufacturer
Deep Blue Medical Advances, Inc.
Date Cleared
2020-03-30
(138 days)
Product Code
FTL
Regulation Number
878.3300Why 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
K041185Device Name
TORSO ARRAY COIL, MODEL 558GE-64
Manufacturer
IGC-MEDICAL ADVANCES, INC.
Date Cleared
2004-05-14
(8 days)
Product Code
MOS
Regulation Number
892.1000Why 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
K040640Device 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
892.1000Why 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
K033292Device 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
892.1000Why 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
K023848Device 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
892.1000Why 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
K023084Device Name
MODEL 472GE-128: QUADRATURE LOWER EXTREMITY COIL
Manufacturer
MEDICAL ADVANCES, INC.
Date Cleared
2002-12-16
(90 days)
Product Code
MOS
Regulation Number
892.1000Why 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
K021433Device 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
892.1000Why 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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