Medical Device Manufacturer · CA , Mississauga

Baylis Medical Technologies, Inc. - FDA 510(k) Cleared Devices

5 submissions · 3 cleared · Since 2023

Recent clearances: Baylis Connector Cable, PrecisePath™ Radiofrequency Puncture Generator and PrecisePath™ Footswitch, PowerWire® 14 Radiofrequency Guidewire Kit

5

Total

3

Cleared

0

Denied

FDA 510(k) Regulatory Record - Baylis Medical Technologies, Inc. Cardiovascular ✕

4 devices

1-4 of 4

Cleared Jan 18, 2026

Baylis Connector Cable

Cardiovascular · 30d

Cleared Sep 11, 2025

PowerWire® 14 Radiofrequency Guidewire Kit

Cardiovascular · 149d

Cleared Feb 28, 2024

PowerWire Radiofrequency Guidewire Kit

Cardiovascular · 188d

Cleared May 30, 2023

RFP-100A Connector Cable (Single Use)

Cardiovascular · 90d