Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3020968442

FEI Number

3020968442

Entity Name

BAYLIS MEDICAL TECHNOLOGIES INC.

City/State/Country

Mississauga Ontario, CA

Establishment Address

2645 Matheson Blvd E, Mississauga Ontario L4W5S4, CA

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

Baylis Medical Technologies Inc. (Owner Number: 10082721)

Owner / Operator Contact Address

2645 Matheson Blvd E, Mississauga, CA-ON L4W5S4, CA

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Destino Steerable Guiding Sheath Nykanen Radiofrequency Wire Kit Nykanen Radiofrequency Wire PowerWire Radiofrequency GuideWire PowerWire Radiofrequency GuideWire Kit OsteoCool Independent Thermocouple Kit OsteoCool RF Ablation Probe Kit Powerwire Pulse Radiofrequency Guidewire Kit RFP-100a Connector Cable (Single Use) PowerWire 14 Radiofrequency Guidewire Kit OsteoCool RF Ablation Probe Kit OsteoCool Independent Thermocouple Kit

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
DYB	Introducer, Catheter	Cardiovascular	Class 2	870.1340	2025-09-02
DYB	Introducer, Catheter	Cardiovascular	Class 2	870.1340	2025-09-29
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2022-03-03
PDU	Catheter For Crossing Total Occlusions	Cardiovascular	Class 2	870.1250	2022-03-03
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2025-12-30
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2022-03-03
DSA	Cable, Transducer And Electrode, Patient, (Including Connector)	Cardiovascular	Class 2	870.2900	2023-06-26
IKD	Cable, Electrode	Physical Medicine	Class 2	890.1175	2025-12-17
DSA	Cable, Transducer And Electrode, Patient, (Including Connector)	Cardiovascular	Class 2	870.2900	2025-11-17
PDU	Catheter For Crossing Total Occlusions	Cardiovascular	Class 2	870.1250	2025-11-17
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2022-01-05

Official Correspondent

Meghal Khakhar

US Agent Details

Yong Sun Business: Emergo Global Representation LLC Email: USAgent@ul.com Phone: (512) 3279997

Related Public Records

Same Entity

Baylis 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
K101883	St Jude Medical	6F ENGAGE/ENGAGE TR INTRODUCER	2010-09-07
K034025	Nmt Medical, Inc.	NMT MEDICAL TRANSSEPTAL SHEATH SET, MODELS TSS-10-HSC, TSS-11-HSC, TSS12-HSC	2004-03-26
K122854	Arrow International (Subsidiary of Teleflex Inc.)	ARROW GLIDETHRU PEEL-AWAY SHEATH/DILATOR INTRODUCER	2013-01-04
K233691	Acutus Medical, Inc.	FlexCath Cross Transseptal Solution	2023-12-17
K915078	North American Instrument Corp.	MORSE HEMOSTATIC CATHETER INTRODUCER SET	1992-06-10

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0783-2020	Abbott Medical	2	Fast-Cath Trio HEMOSTASIS INTRODUCER, 14F, 4.6 mm, REF 406303
Z-0789-2020	Abbott Medical	2	Fast-Cath Hemostasis Introducer, HEMOSTASIS INTRODUCER, 8.5F, 2.83 mm, REF 406143 - Product Usage: The Fast-Cath Hemostasis Introducers are indicated for the introduction of angiographic catheters, closed-end catheters, balloon catheters, and electrodes into a vessel where minimizing blood loss is essential.
Z-0031-06	Rita Medical Systems	2	Rita Brand Habib 4X Electrosurgical Coagulator, Catalog Number: 4401US; Product is distributed by RITA Medical Systems, Inc., One Horizon Way. Manchester, GA 32826

Similar Registrations

Registration Number	Establishment Name	Location
3017689643	CARDIOVIA Ltd.	Nazareth Northern, IL
3041086754	PULNOVO MEDICAL (WUXI) CO., LTD.	Wuxi Jiangsu, CN
3013764800	B. BRAUN MEDICAL INC.	Allentown, PA, US
2020394	BARD PERIPHERAL VASCULAR, INC.	TEMPE, AZ, US
3016904853	SAINT JONES MANAGEMENT LP EOOD	Sofia Sofia-Grad, BG

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3020968442. Last updated year: 2026. Please use registration number 3020968442 when referencing this establishment in official correspondence.