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510(k) Data Aggregation
K Number
K231972Device Name
Advanta VXT Vascular Graft, Flixene Vascular Graft
Manufacturer
Atrium Medical Corporation
Date Cleared
2024-03-28
(269 days)
Product Code
DSY, DYF
Regulation Number
870.3450Why did this record match?
Applicant Name (Manufacturer) :
Atrium Medical Corporation
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Advanta VXT and Flixene vascular grafts are indicated for use in patients with peripheral vascular disease, where peripheral arteries must be repaired or replaced and open surgery is required. Indications for use also includes patients with end stage renal disease requiring arteriovenous vascular access for dialysis.
Device Description
Atrium ePTFE vascular grafts are offered in a variety of designs; (including Advanta VXT and Flixene). They are made primarily of expanded polytetrafluoroethylene (ePTFE), and are available in a wide variety of configurations:
- . "Rings" (also referred to as "helix") for added radial support (made from a PTFE monofilament coil)
- . The Slider Graft Deployment System consisting of a pre-attached tip(s) with a clear flexible sheath (polyethylene)
- . Tapered end
- . Thin or standard wall thickness
The Advanta VXT graft is a 2-layer graft employing a single-layer ePTFE graft, which is then wrapped with an additional layer of ePTFE for increased support. The rings available on some Advanta VXT grafts are bonded to the exterior surface of the graft. By following the prescribed procedure, the rings can be removed incrementally as needed. The Flixene vascular graft is a 3layer graft comprised of ePTFE. This graft was designed with an additional layer of ePTFE. As a result of its design, ring support is not necessary. Implantable portion of graft is comprised of polytetrafluoroethylene (PTFE) with no more than 0.1% cobalt chromite blue-green Spinel ink on surface of the graft, which is used as a reference line. Additional materials in transient contact during placement of the graft include 303 stainless steel and polyethylene, which represents the graft deployment system and transfer sleeve.
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K Number
K201305Device Name
Auto transfusion (ATS) Chest Drains: Ocean Water Seal Chest Drain, Oasis Dry Suction Water Seal Chest Drain, Express Dry Seal Chest Drain
Manufacturer
Atrium Medical Corporation
Date Cleared
2021-09-03
(476 days)
Product Code
CAC
Regulation Number
868.5830Why did this record match?
Applicant Name (Manufacturer) :
Atrium Medical Corporation
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
· Evacuate air and/or fluid from the chest cavity or mediastinum.
· Help re-establish lung expansion and restore breathing dynamics.
Chest Drain Auto transfusion (ATS)
To facilitate collection of autologous blood from the patient's pleural cavity or mediastinal area for reinfusion purposes in postoperative and trauma blood loss management.
Device Description
Atrium's Auto transfusion (ATS) Chest Drains are sterile, single use, disposable devices that mimic a traditional "3 Bottle Systems".
A closed thoracic drainage system (chest drain and catheter together) are used to restore the chest to a more normalized condition after surgery, trauma, or spontaneous need for air and/or fluid to be removed. The Auto transfusion (ATS) features of the drains facilitate postoperative collection and reinfusion of autologous blood from the patient's pleural cavity or mediastinal area.
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K Number
K151386Device Name
C-QUR, C-QUR FX, C-QUR TacShield, C-QUR V-Patch, C-QUR CentriFX, C-QUR Mosaic
Manufacturer
ATRIUM MEDICAL CORPORATION
Date Cleared
2015-10-22
(149 days)
Product Code
FTL
Regulation Number
878.3300Why did this record match?
Applicant Name (Manufacturer) :
ATRIUM MEDICAL CORPORATION
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
C-QUR Mesh is intended for use in soft tissue deficiencies including hernia repair, traumatic or surgical wounds and chest wall reconstruction procedures requiring reinforcement with a non-absorbable supportive material.
Device Description
C-QURTM Mesh is a sterile, knitted polypropylene monofilament mesh material for tissue reinforcement with a bio-absorbable, animal derived oil coating (O3FA) composed of fatty acids, lipids and glycerides. The C-QUR Mesh family is available in various configurations with sizes up to 12" X 18". The devices are terminally sterilized using Ethylene Oxide and intended as a single use device.
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K Number
K151437Device Name
ProLite Mesh, ProLite Ultra Mesh, ProLoop Mesh Plug
Manufacturer
ATRIUM MEDICAL CORPORATION
Date Cleared
2015-08-27
(90 days)
Product Code
FTL
Regulation Number
878.3300Why did this record match?
Applicant Name (Manufacturer) :
ATRIUM MEDICAL CORPORATION
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
ProLite Mesh and ProLite Ultra Mesh are intended for use in soft tissue deficiencies including hernia repair, traumatic or surgical wounds, and chest wall reconstruction procedures requiring reinforcement with a non-absorbable supportive material.
ProLoop Mesh Plug is intended for use in soft tissue deficiencies including hernia repair and traumatic or surgical wounds requiring reinforcement with a non-absorbable supportive material.
Device Description
ProLite™ and ProLite Ultra™ Mesh are sterile, non-absorbable, knitted polypropylene monofilament mesh material. The ProLoop™ Mesh Plug is a non-absorbable, lightweight, pre-formed, three-dimensional plug constructed of knitted rows of monofilament polypropylene with multiple protruding monofilament loops. The devices are available in various configurations with sizes up to 12" X 18". The devices are terminally sterilized using Ethylene Oxide and intended as a single use device.
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K Number
K130142Device Name
FLIXENE IFG VASCULAR GRAFT
Manufacturer
ATRIUM MEDICAL CORPORATION
Date Cleared
2013-03-15
(52 days)
Product Code
DSY
Regulation Number
870.3450Why did this record match?
Applicant Name (Manufacturer) :
ATRIUM MEDICAL CORPORATION
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Atrium Flixene IFG Graft is intended for use in arterial vascular reconstruction, segmental bypass, and for arteriovenous vascular access.
Device Description
Not Found
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K Number
K110110Device Name
ATRIUM CENTRILFX MESH
Manufacturer
ATRIUM MEDICAL CORPORATION
Date Cleared
2011-02-15
(32 days)
Product Code
FTL
Regulation Number
878.3300Why did this record match?
Applicant Name (Manufacturer) :
ATRIUM MEDICAL CORPORATION
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Atrium CentriFX Mesh is indicated for use in hernia repair, chest wall reconstruction, traumatic or surgical wounds and other fascial surgical intervention procedures requiring reinforcement with a nonabsorbable supportive material.
Device Description
Not Found
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