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Sign in to claim this brandBaylis Medical Company Inc.
Canada·CA-MF-000024361
Last updated September 18, 2026
About
Boston Scientific is dedicated to transforming lives through innovative medical solutions that improve the health of patients around the world.
From the manufacturer's own website. Source
Information
- Country
- Canada
- Address
- 5959, Trans-Canada Highway, Montreal, Canada
- Website
- www.bostonscientific.com/
- facebook.com/BostonScientific
- [email protected]
- Phone
- 18882721001 (from company website)
- PRRC Contact
- —
- EUDAMED SRN
- CA-MF-000024361
- FDA FEI Number
- —
- DUNS Number
- —
Catalogue (32)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Nrg™ | NTK3009 | EUDAMED | Class III | Active |
| Nrg™ | NTK3001 | EUDAMED | Class III | Active |
| Nrg™ | NTK3003 | EUDAMED | Class III | Active |
| Nrg™ | NTK3007 | EUDAMED | Class III | Active |
| DuoMode™ | RFX-BAY-DUO-100A | EUDAMEDFDA UDI | Class I | Active |
| Polaris RF Ablation System | K181864 | FDA 510(k) | Class II | Active |
| Epicardial Access System | K213582 | FDA 510(k) | Class II | Active |
| PORTAGE System | K161878 | FDA 510(k) | Class II | Active |
| Baylis Medical Rf Perforation Probe V2.0 | K132374 | FDA 510(k) | Class II | Active |
| ProTrack RF Anchor Wire | K150709 | FDA 510(k) | Class II | Active |
| VersaCross Transseptal Sheath | K183655 | FDA 510(k) | Class II | Active |
| VersaCross Connect Transseptal Dilator | K220414 | FDA 510(k) | Class II | Active |
| ExpanSure Large Access Transseptal Dilator | K201288 | FDA 510(k) | Class II | Active |
| Nexus Suture | K151009 | FDA 510(k) | Class II | Active |
| VersaCross Steerable Sheath, VersaCross Transseptal Dilator | K190688 | FDA 510(k) | Class II | Active |
| ProTrack Pigtail Wire | K213898 | FDA 510(k) | Class II | Active |
| VersaCross Connect™ Transseptal Dilator | K233647 | FDA 510(k) | Class II | Active |
| Diagnostic Fixed Electrophysiology Lumen Catheter , Diagnostic Electrophysiology Cable | K183632 | FDA 510(k) | Class II | Active |
| Mechanical Guidewire | K221351 | FDA 510(k) | Class II | Active |
| Baylis Medical Company Radiofrequency Perforation Generator | K122278 | FDA 510(k) | Class II | Active |
| ExpanSure Transseptal Dilation System | K182064 | FDA 510(k) | Class II | Active |
| Epicardial Access System | K191546 | FDA 510(k) | Class II | Active |
| OsteoCool V-2 RF Ablation System | K142480 | FDA 510(k) | Class II | Active |
| Diagnostic Fixed Electrophysiology Catheter, Diagnostic Electrophysiology Cable | K183649 | FDA 510(k) | Class II | Active |
| SureFlex HD Steerable Sheath, VersaCross HD Steerable Sheath | K231227 | EUDAMEDFDA 510(k) | Class II | Active |
| VersaCross Connect™ Transseptal Dilator | K241720 | FDA 510(k) | Class II | Active |
| OsteoCool V-3 RF Ablation System | K161949 | FDA 510(k) | Class II | Active |
| VersaCross Connect™ Transseptal Dilator | K251325 | FDA 510(k) | Class II | Active |
| OsteoCool V-3 RF Ablation System | K152057 | FDA 510(k) | Class II | Active |
| VersaCross Connect™ | VXAK3003 | EUDAMED | Class III | Active |
| RFP-100A Footswitch | RFA-FS | EUDAMEDFDA UDI | Class I | Active |
| VersaCross™ | VXSK3001 | EUDAMED | Class III | Active |
Related Companies
Authorised Representatives
Importers
Not available yet.
Notified Bodies
Not available yet.
Authorities
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FDA Recalls (4)
Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.
| Date | Recall No. | Class | Status | Reason |
|---|---|---|---|---|
| Oct 7, 2019 | Z-2070-2020 | — | terminated | There is a remote potential for the sterile packaging of the transseptal guiding sheath to be compromised during shipping and handling. In the case that a packaging defect is not identified and the product is used in a patient, there may be a remote risk of infection. |
| Oct 7, 2019 | Z-2069-2020 | — | terminated | There is a remote potential for the sterile packaging of lots of the transseptal guiding sheath to be compromised during shipping and handling. In the case that a packaging defect is not identified and the product is used in a patient, there may be a remote risk of infection. |
| May 12, 2010 | Z-1755-2010 | — | terminated | Name of the device reflected on the product packing sleeve is incorrect. |
| Feb 8, 2010 | Z-0816-2010 | — | terminated | Radiopaque soft tip may fracture. |
FDA Establishments (1)
Establishments registered with the FDA under this company group, matched by name.
- Baylis Medical Co., Inc. US