OCCLUSIN 500 ARTIFICIAL EMBOLIZATION DEVICE
IMBIOTECHNOLOGIES
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 3012120143 | 3012120143 | IMBIOTECHNOLOGIES LTD | 1 | N | 2026-01-01 | 9650 20th Avenue, NW Suite 215 Edmonton Alberta CA T6N 1G1 |
| Source GUDID | Product | Phone | |
|---|---|---|---|
| 07540270000018 | Occlusin 500 - Occlusin 500 is a family of biodegradable, dense, hyperechoic microspheres, which are available in a range of calibrated sizes and marketed under the trade name Ekobi Embolization Microspheres. The microspheres consist of poly-DL-lactic-co-glycolic acid (PLGA) coated with bovine collagen. Following injection into the target vasculature, the collagen binds circulating platelets resulting in a platelet-rich clot which occludes the target vasculature. The microspheres slowly degrade and are removed from the body over 4-6 months. | 1-780-945-6609 | contact@imbiotechnologies.com |
| 07540270000025 | Occlusin 500 - Occlusin 500 is a family of biodegradable, dense, hyperechoic microspheres, which are available in a range of calibrated sizes and marketed under the trade name Ekobi Embolization Microspheres. The microspheres consist of poly-DL-lactic-co-glycolic acid (PLGA) coated with bovine collagen. Following injection into the target vasculature, the collagen binds circulating platelets resulting in a platelet-rich clot which occludes the target vasculature. The microspheres slowly degrade and are removed from the body over 4-6 months. | 1-780-945-6609 | contact@imbiotechnologies.com |
| 07540270000032 | Occlusin 500 - Occlusin 500 is a family of biodegradable, dense, hyperechoic microspheres, which are available in a range of calibrated sizes and marketed under the trade name Ekobi Embolization Microspheres. The microspheres consist of poly-DL-lactic-co-glycolic acid (PLGA) coated with bovine collagen. Following injection into the target vasculature, the collagen binds circulating platelets resulting in a platelet-rich clot which occludes the target vasculature. The microspheres slowly degrade and are removed from the body over 4-6 months. | 1-780-945-6609 | contact@imbiotechnologies.com |
| 07540270000049 | Occlusin 500 - Occlusin 500 is a family of biodegradable dense microspheres which are available in a range of calibrated sizes. The poly-DL-lactic-co-glycolic acid (PLGA) microspheres are surface-coated with bovine collagen. Following injection, the collagen binds patient platelets resulting in a platelet-rich clot which occludes the vasculature. The microspheres slowly degrade and are removed from the body over 4-6 months. | 1-780-945-6609 | contact@imbiotechnologies.com |
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 194037 | 1744320602 | K093813 | OCCLUSIN 500 ARTIFICIAL EMBOLIZATION DEVICE | KRD | 2010-05-10 |
| Product code | Registration listing records | Latest decision |
|---|---|---|
| KRD | 1 | 2010-05-10 |
IMBIOTECHNOLOGIES
2019-05-22
2019-05-22
2019-05-22
2019-01-24
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2019-01-24
2018-08-10