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Sign in to claim this brandBaylis Medical Technologies Inc
US
Last updated May 27, 2026
What Baylis Medical Technologies Inc makes
Baylis Medical Technologies Inc manufactures single-use radiofrequency guidewires and associated kits for peripheral vascular interventions, including the PowerWire and Nykanen series. Their portfolio also includes infusion catheters for vascular procedures and monopolar electrosurgical electrodes designed for endoscopic use.
These devices are classified as Class II under FDA regulations and are authorised via the 510(k) pathway and the FDA’s Unique Device Identification (UDI) system. The company is based in the United States.
Written from this company's registered devices by an AI model, and not verified by a human reviewer.
Frequently asked questions
What types of medical devices does Baylis Medical Technologies Inc manufacture?
Baylis Medical Technologies Inc specialises in single-use medical devices primarily for vascular and endoscopic procedures. Their portfolio includes radiofrequency guidewires (such as the PowerWire and Nykanen series) used in peripheral vascular interventions, infusion catheters for vascular applications, and monopolar electrosurgical electrodes designed for endoscopic use. These devices are engineered to assist in minimally invasive treatments, particularly in cardiovascular and vascular medicine.
Where is Baylis Medical Technologies Inc based?
Baylis Medical Technologies Inc is headquartered in the United States. The company’s location in the US aligns with its focus on serving global markets, particularly those regulated by the FDA, where its devices are authorised for use.
Which regulatory registries or databases list Baylis Medical Technologies Inc’s devices?
Baylis Medical Technologies Inc’s devices are authorised through the FDA’s 510(k) pathway and are also tracked via the FDA’s Unique Device Identification (UDI) system. These registries ensure compliance and traceability of Class II devices, which are subject to stricter regulatory oversight due to their intended use in critical medical procedures.
How are Baylis Medical Technologies Inc’s devices classified under FDA regulations?
Baylis Medical Technologies Inc’s devices fall under Class II classification by the FDA. This classification is assigned based on the level of risk associated with the device’s intended use—Class II devices require special controls beyond general controls to ensure safety and effectiveness, such as performance standards or post-market surveillance. The company’s devices are authorised through the 510(k) process, which demonstrates their compliance with these regulatory requirements.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
- —
- Website
- baylismedtech.com
- —
- —
- [email protected]
- Phone
- 905-948-5800
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- —
- DUNS Number
- 240389677
Catalogue (39)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| AnchorKnot Suture | ASU-0-WB-LR | FDA UDI | Class II | Unknown |
| AnchorKnot Suture | ASU-2-WB-LR | FDA UDI | Class II | Unknown |
| ProTrack Microcatheter | CIC35-145 | FDA UDI | Class II | Active |
| PowerWire Pro Radiofrequency Guidewire Kit | PSK35-250-10-6S | FDA UDI | Class II | Active |
| PowerWire Radiofrequency GuideWire Kit | EWK35-250-10-6S | FDA UDI | Class II | Active |
| AnchorKnot Suture | ASU-2-0-WB-LR | FDA UDI | Class II | Unknown |
| PowerWire Radiofrequency GuideWire Kit | EWK35-250-12-6A-40-12 | FDA UDI | Class II | Active |
| AnchorKnot Suture | ASU-0-W-CL | FDA UDI | Class II | Unknown |
| AnchorKnot Suture | ASU-0-WB-CL | FDA UDI | Class II | Unknown |
| AnchorKnot Suture | ASU-2-0-W-LR | FDA UDI | Class II | Unknown |
| AnchorKnot Suture | ASU-2-W-CL | FDA UDI | Class II | Unknown |
| Nykanen Radiofrequency Wire | RFP-265 | FDA UDI | Class II | Active |
| PowerWire Radiofrequency GuideWire Kit | EWK35-250-12-6A-30-05 | FDA UDI | Class II | Active |
| PowerWire Pulse RF Guidewire Kit | PTK35-250-12-6S | FDA UDI | Class II | Active |
| AnchorKnot Suture Passer (2-0) | PSZ-400-305 | FDA UDI | Class II | Unknown |
| PowerWire Radiofrequency GuideWire Kit | EWK35-250-12-6A-20-05 | FDA UDI | Class II | Active |
| AnchorKnot Suture | ASU-2-0-WB-CL | FDA UDI | Class II | Unknown |
| PowerWire Pro Radiofrequency Guidewire Kit | PSK35-250-12-6A-40 | FDA UDI | Class II | Active |
| Nykanen Radiofrequency Wire kit | RFK-265 | FDA UDI | Class II | Active |
| AnchorKnot Suture | ASU-2-0-W-CL | FDA UDI | Class II | Unknown |
| PowerWire Pulse RF Guidewire Kit | PTK35-250-10-6S | FDA UDI | Class II | Active |
| PowerWire Pro Radiofrequency Guidewire Kit | PSK35-250-12-6A-20 | FDA UDI | Class II | Active |
| AnchorKnot Tissue Approximation Kit | PSZ-400-312 | FDA UDI | Class II | Unknown |
| PowerWire Radiofrequency GuideWire Kit | EWK35-250-12-6S | FDA UDI | Class II | Active |
| AnchorKnot Suture | ASU-2-W-LR | FDA UDI | Class II | Unknown |
| AnchorKnot Suture | ASU-0-W-LR | FDA UDI | Class II | Unknown |
| PowerWire Pro Radiofrequency Guidewire Kit | PSK35-250-12-6A-30 | FDA UDI | Class II | Active |
| PowerWire Radiofrequency GuideWire Kit | EWK35-250-08-6S | FDA UDI | Class II | Active |
| RFP-100A Connector Cable | RFX-BAY-OTW-10-SU | FDA UDI | Class II | Active |
| PowerWire Pro Radiofrequency Guidewire Kit | PSK35-250-12-6S | FDA UDI | Class II | Active |
| AnchorKnot Suture | ASU-2-WB-CL | FDA UDI | Class II | Unknown |
| AnchorKnot Knot Pusher (2-0) and Suture Cutter (2-0) | PSZ-400-311 | FDA UDI | Class II | Unknown |
| ProTrack Microcatheter | CIC38-145 | FDA UDI | Class II | Active |
| PowerWire Pulse RF Guidewire Kit | PTK35-250-08-6S | FDA UDI | Class II | Active |
| Baylis Connector Cable | K254114 | FDA 510(k) | Class II | Active |
| PowerWire Radiofrequency Guidewire Kit | K232562 | FDA 510(k) | Class II | Active |
| PowerWire® 14 Radiofrequency Guidewire Kit | K251158 | FDA 510(k) | Class II | Active |
| RFP-100A Connector Cable (Single Use) | K230571 | FDA 510(k) | Class II | Active |
| PrecisePath™ Radiofrequency Puncture Generator and PrecisePath™ Footswitch | K250275 | FDA 510(k) | Class II | Active |
Related Companies
Authorised Representatives
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Importers
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Authorities
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FDA Establishments (1)
Establishments registered with the FDA under this company group, matched by name.
- Baylis Medical Technologies Inc. Mississauga Ontario · CA FEI 3020968442