Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3013505221

FEI Number

3013505221

Entity Name

ABK BIOMEDICAL

City/State/Country

Halifax Nova Scotia, CA

Establishment Address

155 Chain Lake Drive, Unit 32, Halifax Nova Scotia B3S 1B3, CA

Establishment Type(s)

Complaint File Establishment per 21 CFR 820.198,Manufacture Medical Device

Owner / Operator

ABK Biomedical (Owner Number: 10086030)

Owner / Operator Contact Address

155 Chain Lake Drive, Unit 32, Halifax, CA-NS B3S 1B3, CA

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K234123

PMA Number

N/A

All Registered Proprietary Names

Easi-Vue® embolic microspheres System

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
KRD	Device, Vascular, For Promoting Embolization	Cardiovascular	Class 2	870.3300	2024-03-07

Official Correspondent

Brandi Woods

US Agent Details

Brandi Woods Business: ABK Biomedical, Inc Email: b.woods@abkbiomedical.com Phone: (919) 6196417

Related Public Records

Same Entity

ABK Biomedical

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3013505221. Last updated year: 2026. Please use registration number 3013505221 when referencing this establishment in official correspondence.