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KARDIUM Inc.: FDA-registered device maker in Burnaby British Columbia, Canada, 2 510(k) clearances and 1 PMA approval

Name: KARDIUM Inc. FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

KARDIUM Inc. is registered with the FDA (registration 3007603855) in Burnaby British Columbia, Canada. It lists 8 device types. The FDA files 2 510(k) clearances and 1 PMA approval under its listings, the newest dated August 27, 2025. 1 recall event names it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 3007603855
Address: 8518 Glenlyon Parkway, Unit 155, Burnaby British Columbia, Canada, V5J0B6
Owner or operator: Kardium Inc. (10028366)
Roles: Complaint file establishment, Manufacturer, Specification developer
First device listed: January 23, 2009
Registered through: 2026
Brand names listed: Globe® Catheter, Globe® Catheter Cable Support, Globe® Introducer, Globe® Loader Plug, Globe® Platform, Globe® Pulsed Field System, TORQ

Devices it lists

Device	Product code	Class	Role	Source
Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass	DTL	2	Specification developer	accessdata.fda.gov
Cardiovascular Delivery Catheter System Positioning And Stabilization Device	QWA	1	Complaint file establishment, Manufacturer	accessdata.fda.gov
Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation	OAE	3	Manufacturer	accessdata.fda.gov
Catheter, Steerable	DRA	2	Complaint file establishment, Manufacturer	accessdata.fda.gov
Computer, Diagnostic, Programmable	DQK	2	Complaint file establishment, Manufacturer	accessdata.fda.gov
Introducer, Catheter	DYB	2	Manufacturer	accessdata.fda.gov
Percutaneous Cardiac Ablation Catheter For Treatment Of Atrial Fibrillation With Irreversible Electroporation	QZI	3	Complaint file establishment, Manufacturer	accessdata.fda.gov
Twister, Wire	HXS	1	Specification developer	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
June 25, 2025	K250747	Globe® Pulsed Field System	DQK	Substantially Equivalent	Kardium, Inc.	accessdata.fda.gov
June 3, 2025	K250529	Globe Introducer (601-01001)	DRA	Substantially Equivalent	Kardium, Inc.	accessdata.fda.gov

PMA approvals

Premarket approvals this establishment lists, with the supplements the FDA has decided since.

Approved	PMA number	Device	Product code	Supplements	Latest decision	Source
August 27, 2025	P240044	Globe® Pulsed Field System	QZI	7	October 23, 2026	accessdata.fda.gov

Recalls

Recall events where this establishment is the recalling firm, matched on its FEI.

Initiated	Event	Class	Status	Product	Reason	Source
March 31, 2010	55419	Not yet classified	Terminated	TORQ Sternal Closure Device, SINGLE-USE Intended use: The device is a sterile, single-use only surgical instrument used to tension and twist USP size 5, 6, and 7 (metric size 7.0, 8.0, and 9.0) stainless steel surgical s	A component of the device is installed incorrectly which can result in the component falling out of the device and into the patient during use.	accessdata.fda.gov

Compare with other makers

Updated October 23, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.