Baylis Medical Company, Inc. - FDA 510(k) Cleared Devices
24
Total
24
Cleared
0
Denied
FDA 510(k) cleared devices by Baylis Medical Company, Inc. Cardiovascular ✕
16 devices
Cleared
May 29, 2025
VersaCross Connect™ Transseptal Dilator
Cardiovascular
30d
Cleared
Jul 12, 2024
VersaCross Connect™ Transseptal Dilator
Cardiovascular
28d
Cleared
Dec 20, 2023
SureFlex HD Steerable Sheath, VersaCross HD Steerable Sheath
Cardiovascular
236d
Cleared
Dec 14, 2023
VersaCross Connect™ Transseptal Dilator
Cardiovascular
30d
Cleared
Mar 01, 2023
ProTrack Pigtail Wire
Cardiovascular
442d
Cleared
Dec 19, 2022
Mechanical Guidewire
Cardiovascular
223d
Cleared
Jun 30, 2022
Epicardial Access System
Cardiovascular
230d
Cleared
May 09, 2022
VersaCross Connect Transseptal Dilator
Cardiovascular
84d
Cleared
Jun 12, 2020
ExpanSure Large Access Transseptal Dilator
Cardiovascular
29d
Cleared
Aug 02, 2019
Epicardial Access System
Cardiovascular
51d
Cleared
Jun 07, 2019
Diagnostic Fixed Electrophysiology Lumen Catheter , Diagnostic...
Cardiovascular
163d
Cleared
Jun 07, 2019
Diagnostic Fixed Electrophysiology Catheter, Diagnostic Electrophysiology Cable
Cardiovascular
163d
Cleared
May 20, 2019
VersaCross Transseptal Sheath
Cardiovascular
144d
Cleared
Apr 17, 2019
VersaCross Steerable Sheath, VersaCross Transseptal Dilator
Cardiovascular
30d
Cleared
Mar 21, 2019
ExpanSure Transseptal Dilation System
Cardiovascular
232d
Cleared
Jun 17, 2015
ProTrack RF Anchor Wire
Cardiovascular
90d