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Acutus Medical, Inc. FDA Approvals

0 new drug approvals and 12 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
FlexCath Cross Transseptal Solution510(k)Dec 17, 2023Cardiovascular	Cardiovascular	510(k)Substantially Equivalent (Traditional)	Dec 17, 2023
AcQMap High Resolution Imaging and Mapping System510(k)Jul 10, 2023Cardiovascular	Cardiovascular	510(k)Substantially Equivalent (Traditional)	Jul 10, 2023
AcQMap® High Resolution Imaging and Mapping System510(k)May 2, 2023Cardiovascular	Cardiovascular	510(k)Substantially Equivalent (Traditional)	May 2, 2023
AcQMap High Resolution Imaging and Mapping System510(k)Oct 17, 2022Cardiovascular	Cardiovascular	510(k)Substantially Equivalent (Traditional)	Oct 17, 2022
AcQMap High Resolution Imaging and Mapping System510(k)Jul 1, 2022Cardiovascular	Cardiovascular	510(k)Substantially Equivalent (Traditional)	Jul 1, 2022
AcQMap 3D Imaging and Mapping Catheter, Model 900009510(k)Jun 21, 2022Cardiovascular	Cardiovascular	510(k)Substantially Equivalent (Traditional)	Jun 21, 2022
AcQGuide® VUE Steerable Sheath510(k)May 5, 2022Cardiovascular	Cardiovascular	510(k)Substantially Equivalent (Traditional)	May 5, 2022
AcQCross Qx Integrated Transseptal Dilator/Needle510(k)Feb 8, 2022Cardiovascular	Cardiovascular	510(k)Substantially Equivalent (Traditional)	Feb 8, 2022
AcQMap High Resolution Imaging and Mapping System510(k)Aug 27, 2021Cardiovascular	Cardiovascular	510(k)Substantially Equivalent (Special)	Aug 27, 2021
AcQMap High Resolution Imaging and Mapping System510(k)Aug 5, 2021Cardiovascular	Cardiovascular	510(k)Substantially Equivalent (Traditional)	Aug 5, 2021
AcQGuide MAX Steerable Sheath510(k)May 14, 2021Cardiovascular	Cardiovascular	510(k)Substantially Equivalent (Traditional)	May 14, 2021
AcQCross Qx Integrated Transseptal Dilator/Needle510(k)Apr 6, 2021Cardiovascular	Cardiovascular	510(k)Substantially Equivalent (Traditional)	Apr 6, 2021

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