Data / Medical devices / Canada / ConvaTec Canada Ltd.
ConvaTec Canada Ltd.: FDA-registered device maker in Dorval Quebec, Canada, 5 510(k) clearances
ConvaTec Canada Ltd. is registered with the FDA (registration 3012881740) in Dorval Quebec, Canada. It lists 3 device types. The FDA files 5 510(k) clearances under its listings, the newest dated April 30, 2019. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3012881740
- Address
- 1425 TransCanada Highway Suite 100, Dorval Quebec, Canada, H9P 2V3
- Owner or operator
- ConvaTec (2241599)
- Roles
- Exporter to the US
- First device listed
- May 17, 2007
- Registered through
- 2026
- Brand names listed
- AQUACEL Burn, AQUACEL Extra, AQUACEL Extra Hydrofiber Dressing, AQUACEL Foam, AQUACEL Foam Pro, AQUACEL Hydrofiber, AQUACEL Surgical, Aquacel ConvaFiber and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Dressing, Wound, Hydrophilic | NAC | 1 | Exporter to the US | accessdata.fda.gov |
| Gastrointestinal Tubes With Enteral Specific Connectors | PIF | 2 | Exporter to the US | accessdata.fda.gov |
| Tubes, Gastrointestinal (And Accessories) | KNT | 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 |
|---|---|---|---|---|---|---|
| April 30, 2019 | K190114 | Flexi-Seal PROTECT PLUS Fecal Management System (with ENFit Connector) | KNT | Substantially Equivalent | Convatec Limited | accessdata.fda.gov |
| March 7, 2017 | K162906 | Flexi-Seal PROTECT Fecal Management System | KNT | Substantially Equivalent | Convatec | accessdata.fda.gov |
| July 21, 2015 | K150350 | Flexi-Seal Signal Fecal Management System | KNT | Substantially Equivalent | Convatec, Ltd. | accessdata.fda.gov |
| April 26, 2012 | K112342 | FLEXI-SEAL SIGNAL FECAL MANAGEMENT SYSTEM | KNT | Substantially Equivalent | Convatec, Inc. | accessdata.fda.gov |
| April 8, 2004 | K032734 | CONVATEC FECAL MANAGEMENT SYSTEM | KNT | Substantially Equivalent | Convatec, A Bristol-Myers Squibb Co. | accessdata.fda.gov |
Compare with other makers
- All makers of Tubes, Gastrointestinal (And Accessories)
- All makers of Gastrointestinal Tubes With Enteral Specific Connectors
- All makers of Dressing, Wound, Hydrophilic
Updated April 30, 2019. 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.