Data / Medical devices / Canada / Ates Distribution
Ates Distribution: FDA-registered device maker in Saint-Hubert Quebec, Canada, 3 510(k) clearances
Ates Distribution is registered with the FDA (registration 3024893679) in Saint-Hubert Quebec, Canada. It lists 3 device types. The FDA files 3 510(k) clearances under its listings, the newest dated November 14, 2023. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 3024893679
- Address
- 3165 rue Star, Saint-Hubert Quebec, Canada, J3Y 3W5
- Owner or operator
- Ates Medical (10086840)
- Roles
- Exporter to the US
- First device listed
- December 15, 2022
- Registered through
- 2027
- Brand names listed
- OPN NC PTCA balloon, SunmedTM Inflation Device, UniPearls® Embolic Microspheres
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Catheters, Transluminal Coronary Angioplasty, Percutaneous | LOX | 2 | Exporter to the US | accessdata.fda.gov |
| Device, Vascular, For Promoting Embolization | KRD | 2 | Exporter to the US | accessdata.fda.gov |
| Syringe, Balloon Inflation | MAV | 2 | Exporter to the US | 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 |
|---|---|---|---|---|---|---|
| November 14, 2023 | K231554 | UniPearls® Embolic Microspheres | KRD | Substantially Equivalent | Suzhou Haowei Medical Technology Co., Ltd. | accessdata.fda.gov |
| March 14, 2022 | K212393 | OPN NC PTCA Dilatation Catheter | LOX | Substantially Equivalent | Sis Medical AG | accessdata.fda.gov |
| December 12, 2014 | K133795 | SUMMED INFLATION DEVICE KIT | MAV | Substantially Equivalent | Sunny Medical Device (Shenzhen) Co., Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Catheters, Transluminal Coronary Angioplasty, Percutaneous
- All makers of Device, Vascular, For Promoting Embolization
- All makers of Syringe, Balloon Inflation
Updated November 14, 2023. 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.