Data / Medical devices / Canada / Baylis Medical Technologies Inc.
Baylis Medical Technologies Inc.: FDA-registered device maker in Mississauga Ontario, Canada, 11 510(k) clearances
Baylis Medical Technologies Inc. is registered with the FDA (registration 3020968442) in Mississauga Ontario, Canada. It lists 10 device types. The FDA files 11 510(k) clearances under its listings, the newest dated September 11, 2025. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3020968442
- Address
- 2645 Matheson Blvd E, Mississauga Ontario, Canada, L4W5S4
- Owner or operator
- Baylis Medical Technologies Inc. (10082721)
- Roles
- Complaint file establishment, Contract manufacturer, Exporter to the US, Manufacturer
- First device listed
- January 5, 2022
- Registered through
- 2026
- Brand names listed
- Accurian Enhanced RF Introducer, Accurian Enhanced RF Probe Kit, Accurian RF Cannula, Accurian Reusable RF Probe, Accurian Single Use RF Probe, BMC Connector Cable, Destino Steerable Guiding Sheath, Nykanen Radiofrequency Wire and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Cable, Electrode | IKD | 2 | Contract manufacturer | accessdata.fda.gov |
| Cable, Transducer And Electrode, Patient, (Including Connector) | DSA | 2 | Complaint file establishment, Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Catheter For Crossing Total Occlusions | PDU | 2 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Catheter, Peripheral, Atherectomy | MCW | 2 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Catheter, Septostomy | DXF | 2 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Electrosurgical, Cutting & Coagulation & Accessories | GEI | 2 | Complaint file establishment, Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Generator, Lesion, Radiofrequency | GXD | 2 | Contract manufacturer | accessdata.fda.gov |
| Introducer, Catheter | DYB | 2 | Exporter to the US | accessdata.fda.gov |
| Probe, Radiofrequency Lesion | GXI | 2 | Contract manufacturer | accessdata.fda.gov |
| Wire, Guide, Catheter | DQX | 2 | Complaint file establishment, Manufacturer | 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 |
|---|---|---|---|---|---|---|
| September 11, 2025 | K251158 | PowerWire® 14 Radiofrequency Guidewire Kit | PDU | Unknown | Baylis Medical Technologies, Inc. | accessdata.fda.gov |
| February 28, 2024 | K232562 | PowerWire Radiofrequency Guidewire Kit | PDU | Unknown | Baylis Medical Technologies, Inc. | accessdata.fda.gov |
| May 30, 2023 | K230571 | RFP-100A Connector Cable (Single Use) | DSA | Substantially Equivalent | Baylis Medical Technologies, Inc. | accessdata.fda.gov |
| September 22, 2015 | K151951 | Destino Reach | DYB | Substantially Equivalent | Oscor, Inc. | accessdata.fda.gov |
| April 17, 2014 | K140406 | DESTINO TWIST, STEERABLE GUIDING SHEATH | DYB | Substantially Equivalent | Oscor, Inc. | accessdata.fda.gov |
| August 30, 2013 | K132374 | BAYLIS MEDICAL RF PERFORATION PROBE V2.0 | GEI | Substantially Equivalent | Baylis Medical Company, Inc. | accessdata.fda.gov |
| June 29, 2012 | K120459 | STEERABLE GUIDING SHEATH, MODEL ADELANTE DESTINO | DYB | Substantially Equivalent | Oscor, Inc. | accessdata.fda.gov |
| July 28, 2010 | K101615 | POWERWIRE RADIOFREQUENCY GUIDEWIRE | PDU | Substantially Equivalent | Baylis Medical Co., Inc. | accessdata.fda.gov |
| March 7, 2002 | K014075 | BMC COAXIAL INJECTABLE CATHETER, MODEL CIC 38/145 AND CIC 35/145 | DQX | Substantially Equivalent | Baylis Medical Co., Inc. | accessdata.fda.gov |
| April 9, 2001 | K010265 | BAYLIS MEDICAL RF PERFORATION PROBE, MODEL RFP-265 | GEI | Substantially Equivalent | Baylis Medical Co., Inc. | accessdata.fda.gov |
| February 1, 2001 | K990284 | BAYLIS MEDICAL RF SEPTOSTOMY GENERATOR, NYKANEN RF SEPTOSTOMY CATHETER, BAYLIS MEDICAL CONNECTOR CABLE | DXF | Substantially Equivalent | Baylis Medical Co., Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Cable, Transducer And Electrode, Patient, (Including Connector)
- All makers of Catheter For Crossing Total Occlusions
- All makers of Probe, Radiofrequency Lesion
- All makers of Generator, Lesion, Radiofrequency
- All makers of Electrosurgical, Cutting & Coagulation & Accessories
- All makers of Cable, Electrode
Updated September 11, 2025. 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.