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FDA 510(k) Applications Submitted by May Tsai
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.
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