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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Introducer, Catheter
510(k) Number K233691
Device Name FlexCath Cross Transseptal Solution
Applicant
Acutus Medical, Inc.
2210 Faraday Ave Suite 100
Carlsbad,  CA  92008
Applicant Contact Sarah Clay
Correspondent
REGULATORY TECHNOLOGY SERVICES, LLC
1000 Westgate Drive,
Suite 510k
Saint Paul,  MN  55114
Correspondent Contact Prithul Bom
Regulation Number870.1340
Classification Product Code
DYB  
Subsequent Product Code
DRE  
Date Received11/16/2023
Decision Date 12/17/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
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