Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3018565086

FEI Number

3018565086

Entity Name

FRONT LINE MEDICAL TECHNOLOGIES INC.

City/State/Country

Toronto Ontario, CA

Establishment Address

2 Bloor Street West, Suite 700, Toronto Ontario M4W 3E2, CA

Establishment Type(s)

Complaint File Establishment per 21 CFR 820.198,Develop Specifications But Do Not Manufacture At This Facility

Owner / Operator

Front Line Medical Technologies Inc. (Owner Number: 10083752)

Owner / Operator Contact Address

609 Wellington St., London, CA-ON N6A 3R6, CA

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K201652

PMA Number

N/A

All Registered Proprietary Names

COBRA-OS Custom Sheath Introducer Kit COBRA-OS

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
DRE	Dilator, Vessel, For Percutaneous Catheterization	Cardiovascular	Class 2	870.1310	2024-02-28
MJN	Catheter, Intravascular Occluding, Temporary	Cardiovascular	Class 2	870.4450	2021-12-16

Official Correspondent

Asha Parekh

US Agent Details

Marilyne Joly Business: LOK USA, Inc. Email: regulatory@lok-northamerica.com Phone: (412) 2851076

Related Public Records

Same Entity

Front Line Medical Technologies 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
K051067	LeMaitre Vascular, Inc.	PRUITT F3 OUTLYING AND INLYING CAROTID SHUNT (WITH AND WITHOUT T-PORT)	2005-05-27
K093847	Thermopeutix, Inc.	DUFLO CATHETER (HEPARIN COATED)	2010-08-25

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0013-2009	Edwards Lifesciences, LLC	2	Edwards Lifesciences*Fogarty Fortis*Arterial Embolectomy Catheter Is indicated for the removal of fresh, soft emboli and thrombi from the vessels in the arterial system.

Similar Registrations

Registration Number	Establishment Name	Location
9616662	MERIT MEDICAL IRELAND, LTD	Galway, IE
3011642792	Merit Maquiladora Mexico, S. DE R.L. DE C.V.	Tijuana Baja California, MX
3006950086	Merit Medical Nederland BV	Maastricht Airport Limburg, NL
3015225571	Merit Medical Asia Company Limited	Tsim Sha Tsui, HK
3006082230	C.R. BARD, INC.	MADISON, GA, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3018565086. Last updated year: 2026. Please use registration number 3018565086 when referencing this establishment in official correspondence.