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.


Search | Companies | Product Codes | Device Names | Contacts | Applications | Decisions | Contact