Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3024893679

FEI Number

3024893679

Entity Name

Ates Distribution

City/State/Country

Saint-Hubert Quebec, CA

Establishment Address

3165 rue Star, Saint-Hubert Quebec J3Y 3W5, CA

Establishment Type(s)

Export Device to the United States But Perform No Other Operation on Device

Owner / Operator

Ates Medical (Owner Number: 10086840)

Owner / Operator Contact Address

3165 rue Star, Saint-Hubert, CA-QC J3Y 3W5, CA

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K212393

PMA Number

N/A

All Registered Proprietary Names

SunmedTM Inflation Device OPN NC PTCA balloon

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
MAV	Syringe, Balloon Inflation	Cardiovascular	Class 2	870.1650	2023-09-27
LOX	Catheters, Transluminal Coronary Angioplasty, Percutaneous	Cardiovascular	Class 2	870.5100	2022-12-15

Official Correspondent

Guy Belanger

US Agent Details

Eric Radtke Business: Worldwide Innovations & Technologies inc. Email: eradtke@radpad.com Phone: (913) 6483730

Related Public Records

Same Entity

Ates Medical

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

View Entity Profile →

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0002-2017	Merit Medical Systems, Inc.	2	Merit Inflation Syringe Kit. Catalog Number KOS-02857
Z-0030-04	N/A	2	Ace Percutaneous Transluminal Coronary Angioplasty (PTCA) Dilatation Catheter with 2cm Tip 20 mm Balloon, Catalog Number H74902071011
Z-0031-04	N/A	2	Ace Percutaneous Transluminal Coronary Angioplasty (PTCA) Dilatation Catheter with 2cm Tip 20 mm Balloon, Catalog Number H74902071051
Z-0032-04	N/A	2	Ace Percutaneous Transluminal Coronary Angioplasty (PTCA) Dilatation Catheter with 1 cm Tip and 20 mm Balloon, Catalog Number H74903628151

Similar Registrations

Registration Number	Establishment Name	Location
3007361214	SUNNY MEDICAL DEVICE (SHENZHEN) CO., LTD.	Shenzhen Guangdong, CN
3030446844	PLATINUM FOCUS GROUP LTD.	London London, City of, GB
3004091615	Abbott Vascular Netherlands	Heerlen Limburg, NL
3010149039	FOREFRONT MEDICAL TECHNOLOGY (JIANGSU) CO.,LTD	Changzhou Jiangsu, CN
1526863	ICU Medical, Inc.	DUBLIN, OH, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3024893679. Last updated year: 2026. Please use registration number 3024893679 when referencing this establishment in official correspondence.