FDA 510(k) Applications Submitted by BAYLIS MEDICAL COMPANY INC.

FDA 510(k) Number Submission Date Device Name Applicant
K220414 02/14/2022 VersaCross Connect Transseptal Dilator Baylis Medical Company Inc.
K190688 03/18/2019 VersaCross Steerable Sheath, VersaCross Transseptal Dilator Baylis Medical Company Inc.
K221351 05/10/2022 Mechanical Guidewire Baylis Medical Company Inc.
K201288 05/14/2020 ExpanSure Large Access Transseptal Dilator Baylis Medical Company Inc.
K191546 06/12/2019 Epicardial Access System Baylis Medical Company Inc.
K181864 07/12/2018 Polaris RF Ablation System Baylis Medical Company Inc.
K182064 08/01/2018 ExpanSure Transseptal Dilation System Baylis Medical Company Inc.
K213582 11/12/2021 Epicardial Access System Baylis Medical Company Inc.
K213898 12/14/2021 ProTrack Pigtail Wire Baylis Medical Company Inc.
K150709 03/19/2015 ProTrack RF Anchor Wire BAYLIS MEDICAL COMPANY INC.
K151009 04/15/2015 Nexus Suture BAYLIS MEDICAL COMPANY INC.
K161878 07/08/2016 PORTAGE System Baylis Medical Company Inc.
K161949 07/15/2016 OsteoCool V-3 RF Ablation System Baylis Medical Company Inc.
K152057 07/24/2015 OsteoCool V-3 RF Ablation System BAYLIS MEDICAL COMPANY INC.
K122278 07/30/2012 BAYLIS MEDICAL COMPANY RADIOFREQUENCY PERFORATION GENERATOR BAYLIS MEDICAL COMPANY INC.
K132374 07/30/2013 BAYLIS MEDICAL RF PERFORATION PROBE V2.0 BAYLIS MEDICAL COMPANY INC.
K142480 09/04/2014 OsteoCool V-2 RF Ablation System BAYLIS MEDICAL COMPANY INC.
K183632 12/26/2018 Diagnostic Fixed Electrophysiology Lumen Catheter , Diagnostic Electrophysiology Cable Baylis Medical Company Inc.
K183649 12/26/2018 Diagnostic Fixed Electrophysiology Catheter, Diagnostic Electrophysiology Cable Baylis Medical Company Inc.
K183655 12/27/2018 VersaCross Transseptal Sheath Baylis Medical Company Inc.


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