Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3007603855

FEI Number

3007603855

Entity Name

KARDIUM Inc.

City/State/Country

Burnaby British Columbia, CA

Establishment Address

8518 Glenlyon Parkway, Unit 155, Burnaby British Columbia V5J0B6, CA

Establishment Type(s)

Complaint File Establishment per 21 CFR 820.198,Manufacture Medical Device

Owner / Operator

Kardium Inc. (Owner Number: 10028366)

Owner / Operator Contact Address

8518 Glenlyon Parkway, Unit 155, Burnaby, CA-BC V5J0B6, CA

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K250529

PMA Number

N/A

All Registered Proprietary Names

Globe® Platform Globe® Catheter Cable Support TORQ Globe® Catheter Globe® Pulsed Field System Globe® Introducer

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
QWA	Cardiovascular Delivery Catheter System Positioning And Stabilization Device	Cardiovascular	Class 1	870.3955	2025-09-05
HXS	Twister, Wire	Orthopedic	Class 1	888.4540	2009-01-23
QZI	Percutaneous Cardiac Ablation Catheter For Treatment Of Atrial Fibrillation With Irreversible Electroporation	Unknown	Class 3	N/A	2025-08-28
DRA	Catheter, Steerable	Cardiovascular	Class 2	870.1280	2025-07-29

Official Correspondent

Ricardo Romero

US Agent Details

Doug Goertzen Business: Kardium US Inc. Email: regulatory.affairs@kardium.com Phone: (256) 9078330

Related Public Records

Same Entity

Kardium Inc.

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

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K884337	Catheter Research C/O Burditt, Bowles & Radzius	MICRO-GUIDE SYSTEM	1989-01-05
K162925	Acutus Medical, Inc.	AcQGuide Steerable Sheath	2017-04-06
K221397	ABBOTT MEDICAL	MitraClip G4 Steerable Guide Catheter	2022-09-28

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3007603855. Last updated year: 2026. Please use registration number 3007603855 when referencing this establishment in official correspondence.