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510(k) Data Aggregation

    K Number
    K161137
    Device Name
    Dextera MicroCutter 5/80 Blue Reload, Dextera MicroCutter 5/80 Blue Curved Tip Reload
    Manufacturer
    CARDICA, INC.
    Date Cleared
    2016-07-20

    (89 days)

    Product Code
    GDW
    Regulation Number
    878.4750
    Why did this record match?
    Applicant Name (Manufacturer) :

    CARDICA, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The MicroCutter 5/80 is intended for transection in multiple open or minimally invasive urologic, thoracic, and pediatric surgical procedures, as well as application for transection, and/or creation of anastomoses in the small and large intestine, and the transection of the appendix.
    Device Description
    The size of the Dextera MicroCutter 5/80TM Blue Reload and Dextera MicroCutter 5/80™ Blue Curved Tip Reload staple is compatible with tissue that can be easily compressed to 1.5mm. The size of the Dextera MicroCutter 5/80™ White Reload and Dextera MicroCutter 5/80TM White Curved Tip Reload staple is compatible with tissue that can be easily compressed to 1.0mm. The cut length of the staple line is 28.0mm (1.10in) and the staple line length is 30mm long. The Dextera MicroCutter 5/80™ Reloads are deployed using the Dextera MicroCutter 5/80™ Stapler. The MicroCutter 5/80 Stapler is a single patient use stapler that delivers two, double staggered rows of 316L stainless steel staples while simultaneously transecting tissue between staple rows.
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    K Number
    K151081
    Device Name
    MicroCutter XCHANGE 30 Stapler, MicroCutter XCHANGE 30 Blue Cartridge, MicroCutter XCHANGE 30 White Cartridge
    Manufacturer
    Cardica, Inc.
    Date Cleared
    2016-01-15

    (268 days)

    Product Code
    GDW
    Regulation Number
    878.4750
    Why did this record match?
    Applicant Name (Manufacturer) :

    Cardica, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The MicroCutter XCHANGE® 30 is intended for transection in multiple open or minimally invasive urologic, thoracic, and pediatic surgical procedures, as well as application for transection, and/or creation of anastomoses in the small and large intestine, and the transection of the appendix.
    Device Description
    The MicroCutter XCHANGE® 30 is a single patient use stapler that delivers two, double staggered rows of 316L stainless steel staples while simultaneously transecting tissue between staple rows. The size of the White Cartridge staple is compatible with tissue that can be easily compressed to 1.0mm. The staple line is approximately 30mm long with a transection length of approximately 27mm.
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    K Number
    K140118
    Device Name
    MICROCUTTER XCHANGE 30 STAPLER, MICROCUTTER XCHANGE 30 BLUE CARTRIDGE
    Manufacturer
    CARDICA, INC.
    Date Cleared
    2014-02-25

    (40 days)

    Product Code
    GDW
    Regulation Number
    878.4750
    Why did this record match?
    Applicant Name (Manufacturer) :

    CARDICA, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The MicroCutter XCHANGE™30 is intended for use in multiple open or minimally invasive surgical procedures for the transection, resection, and/or creation of anastomoses in small and large intestine as well as the transection of the appendix.
    Device Description
    The MicroCutter XCHANGE™ 30 Stapler is a single patient use stapler that delivers two. double staggered rows of 316L stainless steel staples while simultaneously transecting tissue between staple rows. The MicroCutter XCHANGE™ 30 Blue Staple Cartridge is available for deployment with the MicroCutter XCHANGE ™ 30 Stapler which delivers a blue staple (3.5mm) compatible with tissue that can be compressed to 1.5mm. The staple line is approximately 30mm long with a transection length of approximately 27mm.
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    K Number
    K140170
    Device Name
    MICROCUTTER XCHANGE 30 STAPLER, MICROCUTTER XCHANGE 30 WHITE CARTRIDGE
    Manufacturer
    CARDICA, INC.
    Date Cleared
    2014-02-19

    (27 days)

    Product Code
    GDW
    Regulation Number
    878.4750
    Why did this record match?
    Applicant Name (Manufacturer) :

    CARDICA, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The MicroCutter XCHANGE™30 is intended for use in multiple open or minimally invasive surgical procedures for the transection, resection, and/or creation of anastomoses in small and large intestine as well as the transection of the appendix.
    Device Description
    The MicroCutter XCHANGE™ 30 Stapler is a single patient use stapler that delivers two, double staggered rows of 316L stainless steel staples while simultaneously transecting tissue between staple rows. The MicroCutter XCHANGE™ 30 White Cartridge is available for deployment with the MicroCutter XCHANGE ™ 30 Stapler and delivers a staple (2.8mm) compatible with tissue that can be compressed to 1.0mm. The staple line is approximately 30mm long with a transection length of approximately 27mm.
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    K Number
    K132581
    Device Name
    MICROCUTTER XCHANGE 30, MICROCUTTER XCHANGE 30, BLUE STAPLE CARTRIDGE, BLUE STAPLE CARTRIDGE
    Manufacturer
    CARDICA, INC.
    Date Cleared
    2014-01-07

    (144 days)

    Product Code
    GDW
    Regulation Number
    878.4750
    Why did this record match?
    Applicant Name (Manufacturer) :

    CARDICA, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The MicroCutter XCHANGE™30 is intended for use in multiple open or minimally invasive surgical procedures for the transection, and/or creation of anastomoses in small and large intestine as well as the transection of the appendix.
    Device Description
    The MicroCutter XCHANGE™ 30 is a single patient use stapler that delivers two, double staggered rows of 316L stainless steel staples while simultaneously transecting tissue between staple rows. The staple (blue; 3.5mm) is compatible with tissue that can be compressed to 1.5mm. The staple line is approximately 30mm long with a transection length of approximately 27mm.
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    K Number
    K101018
    Device Name
    CARDICA C-PORT XA PLUS DISTAL ANASTOMOSIS SYSTEM, MODEL FG-000100
    Manufacturer
    CARDICA, INC.
    Date Cleared
    2010-06-25

    (73 days)

    Product Code
    FZP
    Regulation Number
    878.4300
    Why did this record match?
    Applicant Name (Manufacturer) :

    CARDICA, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Cardica® C-Port® xA Plus Distal Anastomosis System is intended for the creation of anastomoses in blood vessels and grafts, including use in coronary artery bypass grafting procedures.
    Device Description
    The Cardica® C-Port® xA Plus Distal Anastomosis System delivers a series of clips that create an anastomosis between a small target vessel (e.g. coronary artery) and conduit (e.g. saphenous vein graft). An array of metal clips creates a complete, end-to-side anastomosis that is functionally equivalent to a hand-sutured interrupted stitch anastomosis. The system consists of one Anastomosis Device and one Retractor Mount
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    K Number
    K091017
    Device Name
    CARDICA PAS-PORT PROXIMAL ANASTOMOSIS SYSTEM, MODEL FG-000001
    Manufacturer
    CARDICA, INC.
    Date Cleared
    2009-04-29

    (20 days)

    Product Code
    FZP
    Regulation Number
    878.4300
    Why did this record match?
    Applicant Name (Manufacturer) :

    CARDICA, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Cardica® PAS-Port® Proximal Anastomosis System is intended to create the aortic anastomosis of aortic autologous vein grafts.
    Device Description
    The Cardica® PAS-Port® Proximal Anastomosis System is a mechanical device used to facilitate an aortic vein graft anastomosis. The connector replaces sutures to create a secure, patent and reproducible anastomosis. The PAS-Port® Proximal Anastomosis System consists of a connector and a delivery system.
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    K Number
    K090872
    Device Name
    MODIFICATION TO CARDICA C-PORT XA DISTAL ANASTOMOSIS SYSTEM
    Manufacturer
    CARDICA, INC.
    Date Cleared
    2009-04-21

    (22 days)

    Product Code
    FZP
    Regulation Number
    878.4300
    Why did this record match?
    Applicant Name (Manufacturer) :

    CARDICA, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Cardica® C-Port® XATM PLUS™ Distal Anastomosis System is intended for the creation of anastomoses in blood vessels and grafts, including use in coronary artery bypass grafting procedures.
    Device Description
    The Cardica® C-Port® xATM PLUSTM Distal Anastomosis System is a sterile, single use device for creation of a reliably patent end-to-side anastomosis between a conduit and a small vessel. The product consists of accessories to assist in the conduit loading and a device that completes the anastomosis with stainless steel clips. Once the conduit has been loaded onto the device and the device positioned against the target vessel, the anastomosis is created by pushing the actuation button.
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    K Number
    K081225
    Device Name
    CARDICA PAS-PORT PROXIMAL ANASTOMOSIS SYSTEM
    Manufacturer
    CARDICA, INC.
    Date Cleared
    2008-09-05

    (128 days)

    Product Code
    FZP
    Regulation Number
    878.4300
    Why did this record match?
    Applicant Name (Manufacturer) :

    CARDICA, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The PAS•Port® System is intended to create the aortic anastomosis of aortic autologous vein grafts.
    Device Description
    The Cardica® PAS•Port® Proximal Anastomosis System is a mechanical device used to facilitate an aortic vein graft anastomosis. The connector replaces sutures to create a secure, patent and reproducible anastomosis. The PAS•Port® Proximal Anastomosis System consists of a connector and a delivery system.
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    K Number
    K073304
    Device Name
    CARDICA C-PORT X-CHANGE ANASTOMOSIS SYSTEM AND HANDLE AND XA X-CHANGE SUBASSEMBLIES
    Manufacturer
    CARDICA, INC.
    Date Cleared
    2007-12-20

    (27 days)

    Product Code
    FZP
    Regulation Number
    878.4300
    Why did this record match?
    Applicant Name (Manufacturer) :

    CARDICA, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Cardica® Cardica® C-PORT® X-CHANGE™ ANASTOMOSIS SYSTEM is intended for the creation of anastomoses in blood vessels and grafts, including use in coronary artery bypass grafting procedures.
    Device Description
    The Cardica® C-PORT® X-CHANGE™ ANASTOMOSIS SYSTEM is a sterile, single use device for creation of a reliably patent end-to-side anastomosis between a conduit and a small vessel. The product delivers a series of clips that create an anastomosis between a small target vessel (e.g. coronary artery) and a conduit (e.g. saphenous vein graft). The stainless steel clips create a complete end-to-side anastomosis which is functionally equivalent to a hand-sutured, interrupted stitch anastomosis. The system consists of one (1) C-PORT® HANDLE X-CHANGE™ with up to three (3) C-PORT® xA™ X-CHANGE™ subassemblies and one (1) Retractor Mount.
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