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Gelweave Vascular Prosthesis (with the exception of Valsalva variant) are indicated for the repair of damaged and diseased vessels of the thoracic and abdominal aorta in cases of aneurysm, dissection or occlusive disease. Branched configurations can also be used for debranching, i.e. reconstruction of the aortic vessels and associated Hybrid procedures. Hybrid procedures are defined as a treatment combination employing open surgical debranching with endovascular aortic repair. Gelweave Valsalva Vascular Prosthesis are indicated for the repair or replacement of damaged and diseased thoracic aorta, such as aortic root replacement in cases of aneurysm or dissection.

Gelweave™ vascular prostheses are gelatin sealed woven polyester prostheses designed for vascular repair. The Gelweave™ polyester vascular prostheses family, which is this pre-market notification, is based on woven polyester textile technology.

Gelsoft™ Plus Vascular Prostheses are indicated exclusively for vascular repair of damaged and diseased vessels of the abdomen, i.e. replacement or bypass in aneurysmal and occlusive disease of abdominal arteries.

Gelsoft™ Plus vascular prostheses are gelatin sealed knitted polyester prosther repair. The Gelsoft™ Plus polyester vascular prosthesis family, which is the subject of this pre-market notification, is based on knitted polyester textile technology.

Gelseal™ Vascular Prostheses: "Indicated for replacement or bypass of abdominal arteries afflicted with aneurysmal or occlusive disease." Gelsoft™ Vascular Prostheses: "Indicated for abdominal and peripheral vascular repair, i.e. replacement or bypass in aneurysmal and occlusive disease of arteries." Gelsoft™ Plus Vascular Prostheses: "Indicated exclusively for vascular repair of damaged and diseased vessels of the abdomen, i.e. replacement or bypass in aneurysmal and occlusive disease of abdominal arteries."

Gelseal. Gelsoft and Gelsoft Plus vascular prostheses are gelatin sealed knitted polyester prostheses, designed for vascular repair. The Vascutek Gelseal, Gelsoft and Gelsoft Plus polyester vascular prosthesis family, which is the subject of this pre-market notification, is based on knitted polyester textile technology.

Indicated for thoracic reconstruction procedures for replacement of the thoracic aorta in cases of aneurysm, dissection, or coarctation. Indicated for repair or replacement of damaged and diseased vessels of the abdomen in cases of aneurysmal or occlusive disease. Indicated for the repair or replacement of damaged and diseased thoracic aorta in cases of aneurysm, dissection or coarctation. Indicated for repair or replacement of damaged and diseased vessels of the abdomen and thoracic aorta in cases of aneurysm, dissection or coarctation. Repair or replacement of damaged and diseased vessels of the thoracic aorta in cases of aneurysm, dissection or coarctation. Gelweave branched vascular prostheses, including Siena™ vascular prostheses can also be used for debranching, i.e. reconstruction of the aortic vessels and associated Hybrid procedures. Hybrid procedures are defined as a treatment combination employing open surgical debranching with endovascular aortic repair.

Gelweave™ vascular prostheses are gelatin sealed woven polyester grafts, designed for vascular repair. The Vascutek Gelweave polyester vascular graft family, which is the subject of this pre-market notification, is based on woven polyester textile technology.

Gelweave™ branched vascular grafts: "Repair or replacement of damaged and diseased vessels of the abdomen and thoracic aorta in cases of aneurysm, dissection or coarctation". "Gelweave™ branched vascular grafts, including Siena™ grafts can also be used for debranching i.e. reconstruction of the aortic vessels and associated Hybrid procedures".

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Creation of subcutaneous arteriovenous conduits for blood access, bypass or reconstruction of occluded or diseased arterial blood vessels.

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Bypass or reconstruction of peripheral arterial blood vessels

Vascuteks ePTFE vascular grafts were originally cleared by FDA in 1999 (K992832: unsealed and K993667: gelatin sealed). In 2004, Vascutek received clearance for the application of an external ePTFE wrap to the original FDA cleared ePTFE vascular graft range (K041528). As a result of development in line with design control procedures, it became possible to flare the end of a standard wrapped ePTFE graft to create the Cobrahood™ design as shown in Figures 1a and 1b of this submission. The intended use is, "bypass or reconstruction of peripheral arterial blood vessels". All Vascutek ePTFE grafts are manufactured from virgin expanded polytetrafluoroethylene resin, including the ePTFE external wrap. Cobrahood™ ePTFE vascular grafts are not sealed, i.e. do not have an external gelatin coating. The grafts are available with or without an external support constructed of PTFE. This is identical to the support present on the predicate devices, cleared by FDA in 2005 (K041528). All Vascutek ePTFE vascular grafts are supplied sterile. The method of sterilization is Ethylene Oxide. A shelf-life of five years has been established. All related parameters remain unchanged to the predicate grafts. The Cobrahood™ ePTFE vascular graft range is detailed fully in Table 2 of this submission. Manufacturing drawings are provided in Attachment I.

Gelweave "M branched vascular graffs: "Repair of replacentent of damaged and diseased vessels of the abdomen and thoracic aorta in cases of anewrysm, dissection or courclation". Sicua TM grafts vascular with and without Gelweave radiopaque markers: "Repair or replacement of damaged and diseased vessels of the thoracie aorta in cases of anew ysm, dissection or coarctation". "Gelweave" brunched vascular grafts, including Siena" grafts can also be used for debranching i.e. reconstruction of the aortic vessels and associated Hybrid procediires".

The design and all other properties of the Vascutek Gelweave™ branched vascular grafts and Gelweave Siena™ vascular grafts with and without radiopaque markers remain unchanged. The Vascutek Gelweave™ branched vascular grafts and Gelweave Siena™ vascular grafts with and without radiopaque markers function as vascular grafts manufactured from standard polyester and gelatin sealant technologies.

This device is intended to be used in axillary arterial perfusion during cardiopulmonary bypass procedures. These devices are indicated for up to 6 hours of use.

The Vascutek Cannula Graft is a modified device design. It is a combination of a Terumo Soft-Flow® Aortic Cannula (K934127) and a Vascutek SEALPTFE Wrap graft (K041528). It is intended for use in perfusion during cardiopulmonary bypass procedures. The reason for the modification is summarised as follows. Direct introduction of a cannula tip into a patient's blood vessel may cause tissue trauma during attachment of the patient to a cardiopulmonary bypass machine. Replacement of the cannula tip with a softer, SEALPTFE Wrap vascular graft, maybe less traumatic and be preferred by some surgeons. This is the design rationale for the Vascutek Cannula Graft. There are no new materials used in the Vascutek Cannula Graft, other than the use of medical grade adhesive to create the bond between the Terumo Soft-Flow® Cannula (K934127) and Vascuteks SEALPTFE Wrap graft (K041528). Both predicate devices use materials with an extensive history of use in cardiovascular and other medical applications and have been thoroughly tested historically for their respective 510(k) clearances. All materials used in the manufacture of the Vascutek Cannula Graft are biocompatible and non-toxic. The physical properties of the combined predicate devices i.e. the Terumo Soft-Flow® Aortic Cannula (K934127) and the Vascutek SEALPTFE Wrap graft (K041528) remain unchanged and the point of attachment of the component devices has been tested and shown to be suitable for the intended use. The Vascutek Cannula Graft is a finished product, provided sterile for single use only. The overall length of the Vascutek Cannula Graft is approximately 50 cm and the cannula and graft portions are both 8 mm in diameter. The Vascutek Cannula Graft is only available in a single model i.e. a CGS2008S.

THIS DEVICE IS INTENDED TO BE USED AS A TEMPORARY BYPASS SHUNT IN LIMB THREATENING TRAUMA CASES WHERE THERE HAS BEEN DAMAGE TO A MAJOR BLOOD VESSEL

The Temporary Limb Salvage Shunt is a hybrid of two types of commercially available grafts, Rapidax™ (G060186) and MAXIFLO™ (K992832). The Vascutek Rapidax™ graft comprises an internal ePTFE vascular graft and an external eRTFE layer. These are identical to those used in the manufacture of the MAXIFLOTM Wrap grafts. In the Rapidax™ graft these surfaces sandwich a self-sealing elastomer membrane. Vascutek Rapidax™ and MAXIFLO™ Wrap grafts are manufactured from virgin valouter. This PTFE resin is identical to the porycollandoroun-florio (facture of Vascutek's other approved ePTFE vascular grafts. The differences associated with the Temporary Limb Salvage Shunt are summarized as: The absence of the outer ePTFE layer, The addition of a PTFE external support at both ends and middle of the TLSS, The addition of measurement markings along the surface of the TLSS. The Temporary Limb Salvage Shunt is an ePTFE vascular prosthesis which has been modified to facilitate its use as a temporary limb salvage shunt. The device includes an modified to facilitate, external support and graduated markings to allow assessment of depth of insertion. The externally supported bevelled ends facilitate the placing of the device within the severed artery. The support in the centre of the device is required if a shorter length is needed to enable the trauma surgeon to cut the device to the required length. The self-sealing membrane permits drugs to be administered directly into the lumen without loss of ooaling mombrans pormatings assist the surgeon in placement of the correct length.