FDA Registration
Active
🇨🇦 Canada
BAYLIS MEDICAL TECHNOLOGIES INC.
Reg #: 3020968442
·
FEI: 3020968442
·
Expires 2026
Products
10
Proprietary Names
19
Establishment Types
4
Classifications
10
Registration Details
- Registration Name
- BAYLIS MEDICAL TECHNOLOGIES INC.
- Registration Number
- 3020968442
- FEI Number
- 3020968442
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 2645 Matheson Blvd E
- City
- Mississauga Ontario
- Country
- CA
Regulatory Submissions
- 510(k) Number
- K140406
Owner / Operator
- Firm Name
- Baylis Medical Technologies Inc.
- Operator Number
- 10082721
- Address
- 2645 Matheson Blvd E
- City
- Mississauga
- State
- Ontario
- Postal Code
- L4W5S4
- Country
- CA
- Correspondent
- Meghal Khakhar
US Agent
- Business Name
- Emergo Global Representation LLC
- Contact Name
- Yong Sun
- Address
- 2500 Bee Cave Rd., Bldg. 1, Ste. 300
- City
- Austin
- State
- TX
- ZIP
- 78746
- Country
- US
- [email protected]
- Phone
- 512 3279997
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Introducer, Catheter | DYB | Class 2 | Cardiovascular | No | 2025-09-02 |
| Electrosurgical, Cutting & Coagulation & Accessories | GEI | Class 2 | General, Plastic Surgery | No | 2022-03-03 |
| Catheter For Crossing Total Occlusions | PDU | Class 2 | Cardiovascular | No | 2022-03-03 |
| Cable, Transducer And Electrode, Patient, (Including Connector) | DSA | Class 2 | Cardiovascular | No | 2023-06-26 |
| Cable, Electrode | IKD | Class 2 | Physical Medicine | No | 2025-12-17 |
| Wire, Guide, Catheter | DQX | Class 2 | Cardiovascular | No | 2022-03-03 |
| Catheter, Peripheral, Atherectomy | MCW | Class 2 | Cardiovascular | No | 2024-03-07 |
| Probe, Radiofrequency Lesion | GXI | Class 2 | Neurology | No | 2022-01-05 |
| Generator, Lesion, Radiofrequency | GXD | Class 2 | Neurology | No | 2022-01-05 |
| Catheter, Septostomy | DXF | Class 2 | Cardiovascular | No | 2022-03-03 |
Proprietary Names
Destino Steerable Guiding Sheath
Nykanen Radiofrequency Wire Kit
Nykanen Radiofrequency Wire
PowerWire Radiofrequency GuideWire
PowerWire Radiofrequency GuideWire Kit
OsteoCool Independent Thermocouple Kit
OsteoCool RF Ablation Probe Kit
Powerwire Pulse Radiofrequency Guidewire Kit
RFP-100a Connector Cable (Single Use)
PowerWire 14 Radiofrequency Guidewire Kit
BMC Connector Cable
RFP-100A Connector Cable
Protrack Microcatheter
PowerWire Pro Radiofrequency Guidewire Kit
Accurian Enhanced RF Probe Kit
Accurian Reusable RF Probe
Accurian Enhanced RF Introducer
Accurian RF Cannula
Accurian Single Use RF Probe
Establishment Types
Export Device to the United States But Perform No Other Operation on Device
Manufacture Medical Device
Complaint File Establishment per 21 CFR 820.198
Manufacture Medical Device for Another Party (Contract Manufacturer)