Baylis Medical Company, Inc. FDA Approvals

0 new drug approvals and 8 device clearances on file. This applicant is not matched to a listed company.

Newest first

A new drug approval is an original application; a 510(k) is a device shown equivalent to one already sold.

Product	What it is	Route	Decided
VersaCross Connect Transseptal Dilator510(k)May 29, 2025Cardiovascular	Cardiovascular	510(k)Substantially Equivalent (Special)	May 29, 2025
VersaCross Connect Transseptal Dilator510(k)Jul 12, 2024Cardiovascular	Cardiovascular	510(k)Substantially Equivalent (Special)	Jul 12, 2024
SureFlex HD Steerable Sheath, VersaCross HD Steerable Sheath510(k)Dec 20, 2023Cardiovascular	Cardiovascular	510(k)Substantially Equivalent (Traditional)	Dec 20, 2023
VersaCross Connect Transseptal Dilator510(k)Dec 14, 2023Cardiovascular	Cardiovascular	510(k)Substantially Equivalent (Special)	Dec 14, 2023
ProTrack Pigtail Wire510(k)Mar 1, 2023Cardiovascular	Cardiovascular	510(k)Substantially Equivalent (Traditional)	Mar 1, 2023
Mechanical Guidewire510(k)Dec 19, 2022Cardiovascular	Cardiovascular	510(k)Substantially Equivalent (Traditional)	Dec 19, 2022
Epicardial Access System510(k)Jun 30, 2022Cardiovascular	Cardiovascular	510(k)Substantially Equivalent (Special)	Jun 30, 2022
VersaCross Connect Transseptal Dilator510(k)May 9, 2022Cardiovascular	Cardiovascular	510(k)Substantially Equivalent (Special)	May 9, 2022