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Embosphere Microspheres are indicated for use in the embolization of: - Hypervascular tumors, including symptomatic uterine fibroids - Prostatic arteries for symptomatic Benign Prostatic Hyperplasia (BPH) - Arteriovenous malformations - Blood vessels to occlude blood flow to control bleeding/hemorrhaging in the peripheral vasculature

Embosphere Microspheres are small, compressible, hydrophilic, biocompatible spheres made of acrylic polymer and porcine-derived gelatin. The microspheres are packaged in 0.9% saline and are provided sterile and non-pyrogenic in a vial or in a syringe. The product is provided in seven size ranges to allow physicians to choose the appropriate size necessary for the vessel being embolized. The size ranges available are: • 50-100 microns • 40-120 microns • 100-300 microns • 300-500 microns • 500-700 microns • 700-900 microns • 900-1200 microns The principles of operation for the subject device Embosphere Microspheres are the same as the predicate device Embosphere Microspheres (K181300). Embosphere Microspheres are permanent implantable devices and are designed for controlled, targeted embolization. All indications for Embosphere Microspheres; uterine arteries, arteriovenous malformations, hypervascular tumors and prostate arteries all involve arterial embolization. The procedure of arterial embolization is similar for all arteries. Appropriately sized microspheres for target vessel occlusion are chosen by the trained interventional radiologist. The delivery procedure involves arterial access through an artery, using a guidewire and microcatheter under fluoroscopic guidance. Once the catheter tip is placed in the artery(ies) supplying the targeted tissue, Embosphere Microspheres mixed with a non-ionic contrast agent are delivered in a controlled manner under visualization to occlude the feeding vessel(s) to interrupt artery blood flow to the targeted area. The device is intended for single use.

Torpedo Gelatin Foam is indicated for use in embolization of: · Hypervascular tumors · Blood vessels to occlude blood flow to control bleeding / hemorrhaging in the peripheral vasculature

Torpedo Gelatin Foam is a hydrophilic medical device which consists of resorbable dry gelatin foam that is compressed into a cylindrical shape and preloaded into a cartridge with a standard female and male luer fittings. The device is available in two sizes (0.9 mm and 1.7 mm) and two lengths configurations (10 mm and 20 mm). Once rehydrated, the deformable torpedoes can be injected into the target vessel with an intravascular catheter or a micro-catheter (depending on the size range) to provide a mechanical barrier to blood flow. Contrast enhancement may be used to monitor the embolization procedure using fluoroscopy. The device is intended for single use and is provided sterile.

EmboCube Embolization Gelatin is indicated for use in embolization of: - Hypervascular tumors - Blood vessels to occlude blood flow to control bleeding / hemorrhaging in the peripheral vasculature

EmboCube Embolization Gelatin is a hydrophilic, medical device which consists of pre-cut, dry cubes of resorbable gelatin sponge packaged in a syringe. The device is available in 2 cube sizes and 3 weight configurations. Once rehydrated, the deformable cubes can be injected into the target vessel with an intravascular catheter or a micro-catheter (depending on the size range) to provide a mechanical barrier to blood flow. Contrast enhancement may be used to monitor the embolization procedure using fluoroscopy. The device is intended for single use and is provided sterile.

Intended Use: Torpedo Gelatin Foam is indicated for use in embolization of hypervascular tumors.

Torpedo Gelatin Foam is a hydrophilic medical device which consists of resorbable dry gelatin foam that is compressed into a cylindrical shape and preloaded into a cartridge with a standard female and male luer fittings. The device is available in two sizes (0.9 mm and 1.7 mm) and two lengths configurations (10 mm and 20 mm). Once rehydrated, the deformable torpedoes can be injected into the target vessel with an intravascular catheter or a micro-catheter (depending on the size range) to provide a mechanical barrier to blood flow. Contrast enhancement may be used to monitor the embolization procedure using fluoroscopy. The device is intended for single use and is provided sterile.

EmboCube Embolization Gelatin is indicated for use in embolization of hypervascular tumors.

EmboCube Embolization Gelatin is a hydrophilic medical device which consists of pre-cut, dry cubes of resorbable gelatin sponge packaged in a syringe. The device is available in 2 cube sizes and 3 weight configurations. Once rehydrated, the deformable cubes can be injected into the target vessel with an intravascular catheter or a micro-catheter (depending on the size range) to provide a mechanical barrier to blood flow. Contrast enhancement may be used to monitor the embolization procedure using fluoroscopy. The device is intended for single use and is provided sterile.

Embosphere Microspheres are indicated for use in the embolization of: • Hypervascular tumors, including symptomatic uterine fibroids • Prostatic arteries for symptomatic benign prostatic hyperplasia (BPH) • Arteriovenous malformations • Blood vessels to occlude blood flow to control bleeding/hemorrhaging in the peripheral vasculature (subject of this Traditional 510(k))

Embosphere Microspheres are small, compressible, hydrophilic, biocompatible spheres made of acrylic polymer and porcine-derived gelatin. The microspheres are packaged in 0.9% saline and are provided sterile and non-pyrogenic in a vial or in a syringe. The product is provided in seven size ranges to allow physicians to choose the calibration necessary for the vessel being embolized. The size ranges available are: - 50-100 microns - 40-120 microns - 100-300 microns - 300-500 microns - 500-700 microns - 700-900 microns - 900-1200 microns . The principles of operation for the subject device Embosphere Microspheres are the same as the predicate device Embosphere Microspheres (K021397) and reference devices Embosphere Microspheres (K991549, DEN160040). Embosphere Microspheres are permanent implantable devices and are designed for controlled, targeted embolizations for Embosphere Microsphere Microspheres involve arterial embolization; embolization of uterine fibroids, arteriovenous malformations, hypervascular tumors and benign prostatic hyperplasia involve an embolization of the arteries supplying those areas. The procedure of arterial embolization is similar for all arteries. Appropriately sized microspheres for target vessel occlusion are chosen by the trained interventional radiologist. The delivery procedure involves arterial access through an artery, using a quidewire and microcatheter under fluoroscopic guidance. Once the catheter tip is placed in the artery(ies) supplying the targeted tissue Embosphere Microspheres mixed with a non-ionic contrast agent are delivered in a controlled manner under visualization to occlude the feeding vessel(s) to stop blood flow to the targeted area. The device is intended for single use.

QuadraSphere Microspheres are indicated for embolization of hypervascularized tumors including hepatoma, and peripheral arteriovenous malformations.

QuadraSphere Microspheres are sterile, biocompatible, hydrophilic, nonresorbable, expandable, acrylic copolymer microspheres. QuadraSphere Microspheres are packaged in a vial containing 25 mg of dry microspheres. The expansion rate is dependent on ionic concentration. When in contact with blood, non-ionic contrast media, or normal saline (NaCl 0.9%), QuadraSphere Microspheres expand to approximately 4 times their dry state diameter; equal to 64x volume. They are available in a range of sizes.

QuadraSphere Microspheres are indicated for embolization of hypervascularized tumors including hepatoma, and peripheral arteriovenous malformations.

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