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Baylis Medical Company, Inc.

FDA 510(k) & PMA Approved Devices — 18 products

Total Devices18
Categories7
Latest FDA decision2025-05-29
TypeNumberDevice NameCodeDateActions
510(k) K251325 VersaCross Connect™ Transseptal DilatorDRE2025-05-29 View
510(k) K241720 VersaCross Connect™ Transseptal DilatorDRE2024-07-12 View
510(k) K231227 SureFlex HD Steerable Sheath, VersaCross HD Steerable SheathDYB2023-12-20 View
510(k) K233647 VersaCross Connect™ Transseptal DilatorDRE2023-12-14 View
510(k) K213898 ProTrack Pigtail WireDQX2023-03-01 View
510(k) K221351 Mechanical GuidewireDQX2022-12-19 View
510(k) K213582 Epicardial Access SystemDYB2022-06-30 View
510(k) K220414 VersaCross Connect Transseptal DilatorDYB2022-05-09 View
510(k) K201288 ExpanSure Large Access Transseptal DilatorDRE2020-06-12 View
510(k) K191546 Epicardial Access SystemDYB2019-08-02 View
510(k) K183632 Diagnostic Fixed Electrophysiology Lumen Catheter , Diagnostic Electrophysiology CableDRF2019-06-07 View
510(k) K183649 Diagnostic Fixed Electrophysiology Catheter, Diagnostic Electrophysiology CableDRF2019-06-07 View
510(k) K183655 VersaCross Transseptal SheathDYB2019-05-20 View
510(k) K190688 VersaCross Steerable Sheath, VersaCross Transseptal DilatorDYB2019-04-17 View
510(k) K182064 ExpanSure Transseptal Dilation SystemDRE2019-03-21 View
510(k) K181864 Polaris RF Ablation SystemGXD2019-01-02 View
510(k) K161949 OsteoCool V-3 RF Ablation SystemGEI2017-01-31 View
510(k) K161878 PORTAGE SystemHRX2016-09-26 View
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