Medical Device Manufacturer · CA , Mississauga, Ontario

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

24 submissions · 24 cleared · Since 2012
24
Total
24
Cleared
0
Denied

Baylis Medical Company, Inc. has 24 FDA 510(k) cleared medical devices. Based in Mississauga, Ontario, CA.

Latest FDA clearance: May 2025. Active since 2012. Primary specialty: Cardiovascular.

Browse the FDA 510(k) cleared devices submitted by Baylis Medical Company, Inc. Filter by specialty or product code using the sidebar.

24 devices
1–12 of 24
VersaCross Connect? Transseptal Dilator
K251325 · DRE Dilator, Vessel, For Percutaneous Catheterization · Cardiovascular
May 2025 30d
VersaCross Connect? Transseptal Dilator
K241720 · DRE Dilator, Vessel, For Percutaneous Catheterization · Cardiovascular
Jul 2024 28d
SureFlex HD Steerable Sheath, VersaCross HD Steerable Sheath
K231227 · DYB Introducer, Catheter · Cardiovascular
Dec 2023 236d
VersaCross Connect? Transseptal Dilator
K233647 · DRE Dilator, Vessel, For Percutaneous Catheterization · Cardiovascular
Dec 2023 30d
ProTrack Pigtail Wire
K213898 · DQX Wire, Guide, Catheter · Cardiovascular
Mar 2023 442d
Mechanical Guidewire
K221351 · DQX Wire, Guide, Catheter · Cardiovascular
Dec 2022 223d
Epicardial Access System
K213582 · DYB Introducer, Catheter · Cardiovascular
Jun 2022 230d
VersaCross Connect Transseptal Dilator
K220414 · DYB Introducer, Catheter · Cardiovascular
May 2022 84d
ExpanSure Large Access Transseptal Dilator
K201288 · DRE Dilator, Vessel, For Percutaneous Catheterization · Cardiovascular
Jun 2020 29d
Epicardial Access System
K191546 · DYB Introducer, Catheter · Cardiovascular
Aug 2019 51d
Diagnostic Fixed Electrophysiology Lumen Catheter , Diagnostic Electrophysiology Cable
K183632 · DRF Catheter, Electrode Recording, Or Probe, Electrode Recording · Cardiovascular
Jun 2019 163d
Diagnostic Fixed Electrophysiology Catheter, Diagnostic Electrophysiology Cable
K183649 · DRF Catheter, Electrode Recording, Or Probe, Electrode Recording · Cardiovascular
Jun 2019 163d
Filters