Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

9618000

FEI Number

3003245778

Entity Name

NUMED CANADA, INC.

City/State/Country

CORNWALL Ontario, CA

Establishment Address

45 Second Street West, CORNWALL Ontario K6J 1G3, CA

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

NUMED CANADA, INC. (Owner Number: 9044991)

Owner / Operator Contact Address

45 SECOND ST., --, CORNWALL, ONTARIO, CA-NOTA K6J 1G3, CA

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K032591

PMA Number

N/A

All Registered Proprietary Names

Mullins-X Tyshak II Z-MED II Tyshak NuCLEUS COEfficient Mullins-X Tyshak II Z-MED II PTS PTS-X Tyshak Mini NuCLEUS-X NuCLEUS NuCLEUS-X NuCLEUS Z-MED Ghost Tyshak Tyshak Mini

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
OMZ	Pulmonary (Pulmonic) Valvuloplasty Catheters/Percutaneous Valvuloplasty Catheter	Cardiovascular	Class 2	870.1250	2016-04-19
DQY	Catheter, Percutaneous	Cardiovascular	Class 2	870.1250	2007-10-19
DQY	Catheter, Percutaneous	Cardiovascular	Class 2	870.1250	2016-06-10
OMZ	Pulmonary (Pulmonic) Valvuloplasty Catheters/Percutaneous Valvuloplasty Catheter	Cardiovascular	Class 2	870.1250	2007-10-19
DQY	Catheter, Percutaneous	Cardiovascular	Class 2	870.1250	2007-10-19
LIT	Catheter, Angioplasty, Peripheral, Transluminal	Cardiovascular	Class 2	870.1250	2016-06-10
MJN	Catheter, Intravascular Occluding, Temporary	Cardiovascular	Class 2	870.4450	2007-10-19
MJN	Catheter, Intravascular Occluding, Temporary	Cardiovascular	Class 2	870.4450	2007-10-19
DQY	Catheter, Percutaneous	Cardiovascular	Class 2	870.1250	2007-10-19
LIT	Catheter, Angioplasty, Peripheral, Transluminal	Cardiovascular	Class 2	870.1250	2007-10-19
OZT	Balloon Aortic Valvuloplasty	Cardiovascular	Class 2	870.1255	2012-10-16
DQY	Catheter, Percutaneous	Cardiovascular	Class 2	870.1250	2021-01-11
LIT	Catheter, Angioplasty, Peripheral, Transluminal	Cardiovascular	Class 2	870.1250	2007-10-19
DQY	Catheter, Percutaneous	Cardiovascular	Class 2	870.1250	2007-10-19

Official Correspondent

No official correspondent registered.

US Agent Details

NICHELLE LAFLESH Business: NUMED, INC. Email: nlaflesh@numedusa.com Phone: (315) 3284491

Related Public Records

Same Entity

NUMED CANADA, 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
K043580	Chestnut Medical Technologies, Inc.	ALLIGATOR RETRIEVAL DEVICE (ARD)	2005-03-24
K982883	Medtronics Interventional Vascular	MEDTRONIC 7F AND 8F ZUMA GUIDING CATHETER	1998-09-04
K132420	Reflow Medical	WINGMAN EXTENDABLE TIP SUPPORT CATHETER	2013-09-19
K082339	Endocross, Ltd.	ENABLER-P SUPPORT CATHETER	2008-11-20
K210009	CenterPoint Systems, LLC	Guiding Catheter	2021-11-24

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0001-2010	Penumbra Inc.	2	Penumbra Neuron Delivery Catheter 070, percutaneous catheter, catalog numbers PND6F0701058, PND6F070956, PND6F0701058M, and PND6F070956M; manufactured by Penumbra, Inc., Alameda, CA. Indicated for the introduction of interventional devices into the peripheral, coronary, and neuro vasculature.
Z-0003-2014	Cordis Corporation	2	Cordis ADROIT 6F Guiding Catheter Product Usage: For intravascular introduction of interventional and/or diagnostic devices into the coronary or peripheral vascular system.
Z-0009-2024	Boston Scientific Corporation	2	Guider Softip Guide Catheter 6F PRE-SHAPED 40 90CM, Catalog number H965100420, cardiac guide catheter
Z-0010-04	Bard Peripheral Vascular	2	Conquest Balloon Dilation Catheters Model/Catalog Number CQ 75124
Z-0010-2024	Boston Scientific Corporation	2	Guider Softip Guide Catheter 7F PRE-SHAPED 40 90CM, Catalog number H965100430, cardiac guide catheter

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 9618000. Last updated year: 2026. Please use registration number 9618000 when referencing this establishment in official correspondence.