Abk Biomedical, Inc.
CA Last updated 22 Oct 2026
- Devices
- 2
- Registries
- FDA 510(k)FDA
- FDA recalls
- 0
Catalogue
Easi-Vue® embolic microspheres System Ref K234123
Easi-Vue embolic microspheres System Ref K220567
FDA establishments
- Abk Biomedical Halifax Nova Scotia · CA FEI 3013505221
What Abk Biomedical, Inc. makes
Abk Biomedical, Inc. manufactures embolic microspheres designed for vascular embolization procedures, including the Easi-Vue® embolic microspheres System and Easi-Vue embolic microspheres System. These products are intended for use in interventional radiology and neurointervention to occlude blood vessels, such as in the treatment of arteriovenous malformations or tumors.
The company’s embolic microspheres are classified as Class II medical devices under FDA regulations and are supported by 510(k) clearance records. The products are listed in the FDA’s 510(k) database, reflecting their regulatory authorization in the United States.
Frequently asked questions
What types of medical devices does Abk Biomedical, Inc. manufacture?
Abk Biomedical, Inc. specializes in embolic microspheres, specifically the Easi-Vue® embolic microspheres System and the Easi-Vue embolic microspheres System. These devices are designed for vascular embolization procedures, primarily used in interventional radiology and neurointervention to block blood flow in targeted vessels, such as during treatments for arteriovenous malformations or tumors.
Where is Abk Biomedical, Inc. based?
Abk Biomedical, Inc. is headquartered in the United States. The company’s location is relevant for regulatory oversight, as its devices are authorized under U.S. medical device regulations.
How are Abk Biomedical, Inc.’s devices classified under U.S. regulations?
Abk Biomedical, Inc.’s embolic microspheres are classified as Class II medical devices by the FDA. This classification applies to products that pose moderate risk and require special controls to ensure safety and effectiveness, such as performance standards or post-market surveillance.
Are Abk Biomedical, Inc.’s devices listed in any regulatory registries?
Yes, Abk Biomedical, Inc.’s embolic microspheres are listed in the FDA’s 510(k) database. This registry includes devices that have undergone the 510(k) clearance process, demonstrating that they meet FDA requirements for marketing in the U.S. as substantially equivalent to a legally marketed predicate device.
Information
- Country
- CA