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Baylis Medical Company, Inc.

24 FDA 510(k) clearances · Manufacturer

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RecordFirmDate
VersaCross Connect™ Transseptal Dilator (K251325)Baylis Medical Company, Inc.2025-05-29
VersaCross Connect™ Transseptal Dilator (K241720)Baylis Medical Company, Inc.2024-07-12
SureFlex HD Steerable Sheath, VersaCross HD Steerable Sheath (K231227)Baylis Medical Company, Inc.2023-12-20
VersaCross Connect™ Transseptal Dilator (K233647)Baylis Medical Company, Inc.2023-12-14
ProTrack Pigtail Wire (K213898)Baylis Medical Company, Inc.2023-03-01
Mechanical Guidewire (K221351)Baylis Medical Company, Inc.2022-12-19
Epicardial Access System (K213582)Baylis Medical Company, Inc.2022-06-30
VersaCross Connect Transseptal Dilator (K220414)Baylis Medical Company, Inc.2022-05-09
ExpanSure Large Access Transseptal Dilator (K201288)Baylis Medical Company, Inc.2020-06-12
Epicardial Access System (K191546)Baylis Medical Company, Inc.2019-08-02
Diagnostic Fixed Electrophysiology Catheter, Diagnostic Electrophysiology Cable (K183649)Baylis Medical Company, Inc.2019-06-07
Diagnostic Fixed Electrophysiology Lumen Catheter , Diagnostic Electrophysiology Cable (K183632)Baylis Medical Company, Inc.2019-06-07
VersaCross Transseptal Sheath (K183655)Baylis Medical Company, Inc.2019-05-20
VersaCross Steerable Sheath, VersaCross Transseptal Dilator (K190688)Baylis Medical Company, Inc.2019-04-17
ExpanSure Transseptal Dilation System (K182064)Baylis Medical Company, Inc.2019-03-21
Polaris RF Ablation System (K181864)Baylis Medical Company, Inc.2019-01-02
OsteoCool V-3 RF Ablation System (K161949)Baylis Medical Company, Inc.2017-01-31
PORTAGE System (K161878)Baylis Medical Company, Inc.2016-09-26
OsteoCool V-3 RF Ablation System (K152057)Baylis Medical Company, Inc.2015-11-24
Nexus Suture (K151009)Baylis Medical Company, Inc.2015-08-18
ProTrack RF Anchor Wire (K150709)Baylis Medical Company, Inc.2015-06-17
OsteoCool V-2 RF Ablation System (K142480)Baylis Medical Company, Inc.2015-06-16
BAYLIS MEDICAL RF PERFORATION PROBE V2.0 (K132374)Baylis Medical Company, Inc.2013-08-30
BAYLIS MEDICAL COMPANY RADIOFREQUENCY PERFORATION GENERATOR (K122278)Baylis Medical Company, Inc.2012-11-07

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Every clearance here is in the API, with alerts when new ones post.