Baylis Medical Technologies Inc.
Champlain, NY, US
BAYLIS MEDICAL TECHNOLOGIES INC. appears in FDA device records in Champlain, NY. FDA records list 5 510(k) clearances between and , no PMA records and 2 registered establishments. As of , FDA records show no recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 5 510(k) clearances for Baylis Medical Technologies Inc. between 2023 and 2026. The busiest year on record is 2025, with 2. The most recent is 2026, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2023 | 1 |
| 2024 | 1 |
| 2025 | 2 |
| 2026 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K254114 | Baylis Connector Cable | DSA | Substantially Equivalent | |
| K250275 | PrecisePath™ Radiofrequency Puncture Generator and PrecisePath™ Footswitch | GEI | Substantially Equivalent | |
| K251158 | PowerWire® 14 Radiofrequency Guidewire Kit | PDU | Unknown | |
| K232562 | PowerWire Radiofrequency Guidewire Kit | PDU | Unknown | |
| K230571 | RFP-100A Connector Cable (Single Use) | DSA | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3020968442 | 3020968442 | BAYLIS MEDICAL TECHNOLOGIES INC. | 2645 Matheson Blvd E, Mississauga Ontario L4W5S4 CA | 2026 | |
| 3020689212 | 3020689212 | Baylis Medical Technologies Inc. | 11320 State Route 9, Champlain, NY 12919 US | 2026 | No device listings on this registration |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- IKDCable, Electrode
- DSACable, Transducer And Electrode, Patient, (Including Connector)
- PDUCatheter For Crossing Total Occlusions
- MCWCatheter, Peripheral, Atherectomy
- DXFCatheter, Septostomy
- GEIElectrosurgical, Cutting & Coagulation & Accessories
- GXDGenerator, Lesion, Radiofrequency
- DYBIntroducer, Catheter
- GXIProbe, Radiofrequency Lesion
- DQXWire, Guide, Catheter
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain