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510(k) Data Aggregation

    K Number
    K211183
    Device Name
    Sugita AVM Microclips
    Manufacturer
    Mizuho America, Inc.
    Date Cleared
    2022-03-02

    (316 days)

    Product Code
    HCH
    Regulation Number
    882.5200
    Why did this record match?
    Product Code :

    HCH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Sugita AVM Microclips are designed for occlusion of fragile capillary vessels to stop bleeding from arteriovenous malformations and other analogous venous structures. Sugita AVM Microclips are not intended as a replacement for bipolar electrocoagulation of smaller vessels nor do they negate the need for immediate post-operative angiography following arteriovenous malformation surgery.
    Device Description
    The Sugita AVM Microclips were cleared by the FDA through 510(k) K960037. The Sugita AVM Microclips are manufactured from Elgiloy, a cobalt-chromiummolybdenum alloy. They are designed for the occlusion of fragile capillary vessels to stop bleeding from arteriovenous malformations and other analogous venous structures. The Sugita AVM Microclips are available in the following sizes: 2mm, 3mm, 4mm and 5mm. Other than the modifications identified above, there have been no other changes to the Sugita AVM Microclips.
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    K Number
    K180757
    Device Name
    D-Clip; D-Clip Applier
    Manufacturer
    Peter Lazic GmbH
    Date Cleared
    2019-04-12

    (386 days)

    Product Code
    HCH, HCI
    Regulation Number
    882.5200
    Why did this record match?
    Product Code :

    HCH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Permanent D-Aneurysm-Clips are intended for permanent occlusion of cerebral aneurysms. Temporary D-Aneurysm-Clips are intended for temporary occlusion of intracranial blood vessels and cerebral aneurysms. The D-Aneurysm Clip Appliers are intended to be used for holding and applying D-Aneurysm-Clips. The D-Aneurysm Clip Appliers are not compatible with other systems.
    Device Description
    D-Aneurysm-Clips are available in two principle sizes (Standard and Mini) and several forms of jaws (straight, curved, angled, bayonet, fenestrated, non-fenestrated). Both sizes are available for permanent or temporary occlusion. D-Aneurysm Clip Appliers are designed to be used with both principle sizes of D-Aneurysm-Clips, Standard and Mini. The D-Clip is manufactured out of three parts, two of those forming the body and one the spring. With D-Clip Appliers it is grasped from the outside to open, close and guide the clip. The D-Clip Appliers exists in two versions: a version with double action handles and one version with memory effect. Both versions are applied the same way. Pressing the handle will open the jaw.
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    K Number
    K131500
    Device Name
    YASARGIL ANEURYSM CLIPS AND CLIP APPLIERS
    Manufacturer
    AESCULAP, INC.
    Date Cleared
    2014-01-24

    (245 days)

    Product Code
    HCH, HCI
    Regulation Number
    882.5200
    Why did this record match?
    Product Code :

    HCH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Yasargil Aneurysm Clips are intended for occlusion of cerebral aneurysms in either a temporary or permanent manner. They are applied with Aesculap clip appliers, which contain titanium alloy or phynox jaws.
    Device Description
    The Yasargil Aneurysm Clips are designed for temporary or permanent occlusion of vessels during neurosurgical procedures. They are manufactured from either titanium alloy according to ISO 5832/3 or phynox (cobalt alloy) per ISO 5832/7. The clips range in size from 3 mm to 40 mm and are available in straight, curved, angled, bayonet. T-bar, offset T-bar, concave T-bar, fenestrated, and non-fenestrated styles. The Yasargil Clip Appliers are manufactured from stainless steel (body) with either a titanium allov or phynox jaw. The appliers are available in short (50mm), standard (90 mm) and long (110 mm) lengths, as well as straight, angled and bayonet shapes.
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    K Number
    K091921
    Device Name
    CODMAN ANEURYSM CLIPS, CODMAN AVM MICRO CLIP SYSTEM, CODMAN SLIM-LINE GRAFT, REINFORCING, MINI ANEURYSM CLIP
    Manufacturer
    Codman & Shurtleff, Inc.
    Date Cleared
    2009-09-08

    (70 days)

    Product Code
    HCH
    Regulation Number
    882.5200
    Why did this record match?
    Product Code :

    HCH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Codman Slim Line Standard Clip is used for permanent occlusion of intracranial aneurysm. Codman Slim Line Mini Clip is used for the occlusion of small vessels when controlling bleeding on arteriovenous malformations or other similar venous structures. Codman Slim-Line Graft clip is used to encircle an artery in which a hole has developed as a result of a traumatic injury to the vessel or from an aneurysm tearing at its base that cannot be sutured as the hole is in such a position that it is difficult for the surgeon to rotate a needle. Codman Slim-Line Reinforcing clip is used to reinforce aneurysm clips that may not be of adequate strength to occlude the aneurysm. Codman Slim-Line Temporary Aneurysm Clip is used for the occlusion of small vessels when controlling bleeding on arteriovenous malformations or other similar venous structure. Codman AVM Micro Clip System is designed for occlusion of small vessels when controlling bleeding on arteriovenous malformation or other smaller venous structures.
    Device Description
    Aneurysm clips have two parts, a spring section and two blades. The spring section determines the strength of the clip. The blades grasp the aneurysm.
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    K Number
    K081640
    Device Name
    GIMMI ANEURYSM CLIPS AND APPLYING FORCEPS
    Manufacturer
    GIMMI GMBH
    Date Cleared
    2009-05-06

    (329 days)

    Product Code
    HCH
    Regulation Number
    882.5200
    Why did this record match?
    Product Code :

    HCH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Permanent GIMMI Aneurysm Clips (Yasargil) and vessel clips are intended for Permanent occlusion of blood vessels and cerebral aneurysms. Likewise, temporary permianent occlusion of blood vessel clips are intended for temporary occlusion Gilvilli Aneurysin Olips (Tabargi) and cerebral aneurysms. They are also intended to be applied exclusively with the corresponding Clip Appliers.
    Device Description
    GIMMI Aneurysm Clips and their Clip Applying Forceps are used for the occlusion of aneurysms. "Mini" and "Standard" Clips can only be applied with the according Applying forceps; these forceps are labelled with "Mini" or "Standard". Clips are available in different sizes and shapes, to have the right size and shape due to the size and shape of the aneurysm.
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    K Number
    K081489
    Device Name
    L-ANEURYSM-CLIP SYSTEM & L-ANEURYSM CLIP APPLIERS, YASARGIL ANEURYSM CLIPS & YASARGIL ANEURYSM CLIP APPLIERS
    Manufacturer
    PETER LAZIC GMBH
    Date Cleared
    2008-09-25

    (120 days)

    Product Code
    HCH
    Regulation Number
    882.5200
    Why did this record match?
    Product Code :

    HCH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Permanent L-Aneurysm-Clips and YASARGIL aneurysm and vessel clips are intended for permanent occlusion of blood vessels and cerebral aneurysms. Likewise, temporary L-Anaurysm-Clins and Yasargil aneurysm and vessel clips are intended for temporary occlusion of intra cranial blood vessels and cerebral aneurysms. The L-Aneurysm-Clip Appliers are intended to be used for holding and applying L-Aneurysm-Clips. The Yasargil-Aneurysm-Clip Appliers are intended to be used for holding and applying Yasargil-Aneurysm-Clips. The L-Aneurysm-Clip Appliers and the Yasargil-Aneurysm-Clip Appliers are not compatible to other traded systems.
    Device Description
    L-Aneurysm Clips and Yasargil-Aneurysm Clips are available in two principle sizes (Standard and Mini) and several forms of jaws (straight, curved, angled, bayonet, fenestrated, non-fenestrated). Both sizes are available for permanent or temporary occlusion. L-Aneurysm Clip Appliers are designed to be used with both principle sizes of L-Aneurysm Clips. Yasargil Clip Appliers are available in two principle sizes (Standard and Mini), matching the respective size of the applied Yasargil Aneurysm Clip.
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    K Number
    K060915
    Device Name
    KIRWAN L-ANEURYSM CLIPS AND APPLIER, KIRWAN YASARGIL-TYPE ANEURYSM CLIPS AND APPLIERS
    Manufacturer
    KIRWAN SURGICAL PRODUCTS, INC.
    Date Cleared
    2007-04-17

    (378 days)

    Product Code
    HCH
    Regulation Number
    882.5200
    Why did this record match?
    Product Code :

    HCH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Kirwan 45.XXX and 65.XXX Series of Aneurysm Clips are intended for either temporary or permanent occlusion of intracranial aneurysms. They are also intended to be applied exclusively with the Kirwan 45.XXX and 65.XXX Series Appliers.
    Device Description
    The Kirwan 45.XXX and 65.XXX Series of Aneurysm Clips are intended for either temporary or permanent occlusion of intracranial aneurvsms. They are also intended to be applied exclusively with the 45.XXX and 65.XXX Series Appliers.
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    K Number
    K043041
    Device Name
    AESCULAP T-BAR ANEURYSM CLIPS (TITANIUM & PHYNOX)
    Manufacturer
    AESCULAP, INC.
    Date Cleared
    2004-12-09

    (35 days)

    Product Code
    HCH
    Regulation Number
    882.5200
    Why did this record match?
    Product Code :

    HCH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Aesculap T-Bar Aneurysm Clips are intended for occlusion of cerebral aneurysms in either a temporary or permanent manner.
    Device Description
    The Aesculap T-Bar Aneurysm Clips are designed for temporary or permanent occlusion of vessels during neurosurgical procedures. They are made from either Phynox (oobalt alloy) per ISO 5832/7 or Titanium Alloy per ISO 5832/3. The clips are a fennstrated design with the jaws at 90 and 45 degree angles. They are applied with previously cleared Aesculap aneurysm clip appliers.
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    K Number
    K032198
    Device Name
    AESCULAP YASARGIL ANEURYSM CLIP PHYNOX BOOSTER CLIP
    Manufacturer
    AESCULAP, INC.
    Date Cleared
    2003-08-20

    (33 days)

    Product Code
    HCH
    Regulation Number
    882.5200
    Why did this record match?
    Product Code :

    HCH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Aesculap Yasargil Aneurysm Clip Booster Clip is intended to be used for increasing the closing force of standard permanent aneurysm clips to occlude cerebral aneurysms.
    Device Description
    The Aesculap Yasarqil Aneurysm Clip Booster Clip is designed to provide additional pressure for occlusion of cerebral aneurysms when used with a standard aneurysm clip during neurosurgical procedures. They are made from Phynox (cobalt alloy) per ISO 5832/7 and are for use with Phynox aneurysm clips only.
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    K Number
    K031468
    Device Name
    TEMPORARY TITANIUM ANEURYSM CLIP
    Manufacturer
    Cardinal Health
    Date Cleared
    2003-06-20

    (42 days)

    Product Code
    HCH, HCI
    Regulation Number
    882.5200
    Why did this record match?
    Product Code :

    HCH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Temporary placement in the brain to facilitate occlusion of cerebral aneurysms. Clips are only to be applied with V. Mueller titanium coated clip appliers.
    Device Description
    The temporary titanium aneurysm clip is bent wire that provides a spring operated, self-closing aneurysm clip of various lengths/sizes.
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