FDA 510(k) Application Details - K210685

Device Classification Name	Introducer, Catheter   More FDA Info for this Device
510(K) Number	K210685
Device Name	Introducer, Catheter
Applicant	Acutus Medical Inc. 2210 Faraday Ave, Suite 100 Carlsbad, CA 92008 US Other 510(k) Applications for this Company
Contact	Sarah Clay Other 510(k) Applications for this Contact
Regulation Number	870.1340   More FDA Info for this Regulation Number
Classification Product Code	DYB Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	03/08/2021
Decision Date	04/06/2021
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CV - Cardiovascular
Review Advisory Committee	CV - Cardiovascular
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	Y
Expedited Review